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Optum Rx news and resources
03/29/24
Eugia – Recall of methocarbamol injection
March 28, 2024 - Eugia announced a consumer-level recall of one lot of methocarbamol injection because of a customer complaint for the presence of white particles floating inside the vial.
05/02/24
EpiHealth declares bankruptcy – Recalls Cloderm® (clocortolone pivalate) and Minolira™ (minocycline)
April 24, 2024 - EpiHealth announced a voluntary consumer-level recall of some lots of Cloderm (clocortolone pivalate) topical cream and Minolira (minocycline) extended-release tablets as a result of the company declaring bankruptcy in July 2023.
09/26/24
Aqneursa™ (levacetylleucine) – New drug approval
September 25, 2024 - IntraBio announced the FDA approval of Aqneursa (levacetylleucine), for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.
09/27/24
Dupixent® (dupilumab) for COPD – New indication approval
September 27, 2024 - Regeneron and Sanofi announced the approval of a new indication for Dupixent® (dupilumab) for chronic obstructive pulmonary disease COPD). Dupixent is now approved as add-on maintenance treatment in adults with uncontrolled COPD and an eosinophilic phenotype.
01/17/25
Lumakras® (sotorasib) plus Vectibix® (panitumumab) – New indication
January 17, 2025 - Amgen announced the FDA approval of Lumakras (sotorasib), in combination with Vectibix (panitumumab), for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
09/01/24
Ocrevus Zunovo™ (ocrelizumab/hyaluronidase-ocsq) – New subcutaneous formulation approval
September 13, 2024 - Halozyme announced that Roche received FDA approval of Ocrevus Zunovo (ocrelizumab/hyaluronidase-ocsq), for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; and primary progressive MS.
03/05/24
Xofluza® (baloxavir marboxil) – Expanded indication
March 1, 2024 - The FDA approved Genentech’s Xofluza (baloxavir marboxil), for treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.
11/20/24
Endo – Expanded recall of clonazepam orally disintegrating tablets
November 18, 2024 - Endo announced a voluntary, consumer level recall of many lots of clonazepam ODT tablets because of potential product carton strength mislabeling. The recall was first announced on July 5, 2024.
10/14/24
Imuldosa™ (ustekinumab-srlf) – New biosimilar approval
October 10, 2024 - Accord announced the FDA approval of Imuldosa (ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab).
01/23/26
RxNews - January 23, 2026
Zylet® (loteprednol etabonate/tobramycin) – First-time generic
06/20/24
Capvaxive™ (pneumococcal 21-valent conjugate vaccine) – New vaccine approval
June 17, 2024 - Merck announced the FDA approval of Capvaxive (pneumococcal 21-valent conjugate vaccine), for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae (S. pneumoniae) serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older. Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
11/20/24
Revuforj® (revumenib) – New orphan drug approval
November 15, 2024 - Syndax announced the FDA approval of Revuforj (revumenib), for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
08/06/25
Ixchiq® (Chikungunya vaccine, live) – FDA removes pause in use in patients 60 years and older
August 6, 2025 - The FDA removed the recommended pause in the use of Ixchiq (Chikungunya vaccine, live) in individuals 60 years of age and older and has approved updates to the prescribing information and patient information.
01/07/22
Moderna COVID-19 Vaccine – Expanded emergency use authorization
On January 7, 2022, the FDA announced expanded emergency use authorization (EUA) for the Moderna COVID-19 vaccine, a single Moderna COVID-19 vaccine booster dose (0.25 mL) may be administered at least 5 months after completing a primary series of the Moderna COVID-19 vaccine to individuals 18 years of age or older.
11/07/25
RxNews - November 7, 2025
Kygevvi® (doxecitine/doxribtimine) – New orphan drug approval<br>Grifols – Withdrawal of Gamunex®-C (immune globulin [human]) 10% injection<br>Otsuka ICU Medical – Recall of potassium chloride injection<br>Dalvance® (dalbavancin) – First-time generic
03/04/24
Letybo (letibotulinumtoxinA-wlbg) – New drug approval
March 4, 2024 - Hugel announced the FDA approval of Letybo (letibotulinumtoxinA-wlbg), for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity in adult patients.
02/28/25
Ascent Consumer Products – Recall of SinuCleanse® Soft Tip Squeeze Bottle Nasal Wash System
February 25, 2025 - Ascent Consumer Products announced a consumer level recall of one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System because of a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S. aureus).
09/12/25
RxNews - September 12, 2025
Vonvendi® (von Willebrand factor [recombinant]) – Expanded indications<br>Otezla XR™ (apremilast) – New drug approval
04/04/24
Zevtera (ceftobiprole medocaril sodium) – New drug approval
April 3, 2024 - The FDA announced the approval of Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium), for the treatment of Adult patients with Staphylococcus aureus bloodstream infection (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates; Adult patients with acute bacterial skin and skin structure infections caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae; Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae.
08/05/24
Brineura® (cerliponase alfa) – Expanded indication
July 24, 2024, BioMarin announced the FDA approval of Brineura (cerliponase alfa), to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
04/05/24
Abecma® (idecabtagene vicleucel) – Expanded indication
April 5, 2024 - Bristol Myers Squibb and 2seventy bio announced the FDA approval of Abecma (idecabtagene vicleucel), for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
01/16/24
FDA evaluates reports of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
January 11, 2024 - The FDA announced results from a preliminary evaluation did not show a causal link between suicidal thoughts or actions in patients treated with GLP-1 RAs.
01/09/26
RxNews - January 9, 2026
Cablivi® (caplacizumab-yhdp) – Expanded indication<br>Nereus™ (tradipitant) – New drug approval<br>Eli Lilly – Discontinuation of Omvoh® (mirikizumab-mrkz) 100 mg/mL subcutaneous injection
01/17/24
Indocin® (indomethacin) – First-time generic
January 16, 2024 - ANI Pharmaceuticals launched an AB-rated generic version of Zyla Life Sciences’ Indocin (indomethacin) oral suspension.
04/23/24
Myrbetriq® (mirabegron) – First-time generic launch halted
April 23, 2024 - The Federal Circuit court issued a temporary injunction halting Lupin and Zydus launch of AB-rated generic versions of Astellas’ Myrbetriq (mirabegron) 25 mg extended-release tablets.
02/15/24
Onivyde® (irinotecan liposome injection) – New indication
February 13, 2024 - Ipsen announced the FDA approval of Onivyde (irinotecan liposome injection), in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma.
12/16/24
Nemluvio® (nemolizumab-ilto) – New indication
December 13, 2024 - Galderma announced the FDA approval of Nemluvio (nemolizumab-ilto), for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
08/12/24
Lymphir™ (denileukin diftitox-cxdl) – New orphan drug approval
August 8, 2024 - Citius Pharmaceuticals announced the FDA approval of Lymphir (denileukin diftitox-cxdl), for the treatment of adult patients with relapsed or refractory stage I - III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
01/16/24
FDA authorizes foreign importation of Bicillin® L-A (penicillin G benzathine)
FDA authorizes foreign importation of Bicillin® L-A (penicillin G benzathine)
07/31/25
Leqvio® (inclisiran) – Expanded indication
July 31, 2025 - Novartis announced the FDA approval of Leqvio (inclisiran), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
08/13/24
Enzeevu™ (aflibercept-abzv) – New biosimilar approval
August 12, 2024, Sandoz announced the FDA approval of Enzeevu (aflibercept-abzv), biosimilar to Regeneron’s Eylea® (aflibercept).
03/04/25
Osenvelt® (denosumab-bmwo) – New biosimilar approval
March 3, 2025 - Celltrion announced the FDA approval of Osenvelt (denosumab-bmwo), biosimilar to Amgen’s Xgeva® (denosumab).
01/26/24
Dupixent® (dupilumab) – Expanded indication
January 25, 2024 - Regeneron and Sanofi announced the FDA approval of Dupixent (dupilumab), for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
09/27/24
Cobenfy™ (xanomeline and trospium hydrochloride) – New drug approval
September 26, 2024 - The FDA announced the approval of Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium hydrochloride capsules) or the treatment of schizophrenia in adults.
03/19/24
Lenmeldy™ (atidarsagene autotemcel) – New orphan drug approval
March 18, 2024 - The FDA announced the approval of Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), for the treatment of children with pre-symptomatic late infantile (PSLI), presymptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).
07/19/24
Voquezna® (vonoprazan) – New indication
July 18, 2024 - Phathom Pharmaceuticals announced the FDA approval of Voquezna (vonoprazan), for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adults.
04/09/24
Carvykti® (ciltacabtagene autoleucel) – Expanded indication
April 5, 2024 - Johnson & Johnson announced the FDA approval of Carvykti (ciltacabtagene autoleucel), for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
10/10/25
RxNews - October 10, 2025
COVID-19 and Measles, Mumps, Rubella and Varicella (MMRV) vaccines – CDC Director adopts ACIP recommendations<br>Tecentriq® (atezolizumab) or Tecentriq Hybreza® (atezolizumab/hyaluronidase-tqjs) plus Zepzelca® (lurbinectedin) – New indication<br>Zoryve® (roflumilast) – Expanded indication, new strength<br>Eydenzelt® (aflibercept-boav) – New biosimilar approval<br>Jascayd® (nerandomilast) – New orphan drug approval<br>Qivigy® (immune globulin intravenous, human-kthm) – New drug approval<br>Rhapsido® (remibrutinib) – New drug approval<br>Grifols – Withdrawal of Gamunex®-C (immune globulin [human]) 10% injection
09/04/24
Prevymis® (letermovir) – Expanded indication, new dosage formulation
August 30, 2024 - The FDA approved Merck’s Prevymis (letermovir), for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT), and for prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]).
11/27/24
Ziihera® (zanidatamab-hrii) – New orphan drug approval
November 20, 2024 - Jazz Pharmaceuticals announced the FDA approval of Ziihera (zanidatamab-hrii), for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
12/17/24
Vtama® (tapinarof) – New indication
December 12, 2024 - The FDA approved Dermavant Sciences’ Vtama (tapinarof), for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
03/04/25
Odactra® (Dermatophagoides farinae and Dermatophagoides pteronyssinus) – Expanded indication
February 27, 2025 - ALK announced the FDA approval of Odactra (Dermatophagoides farinae and Dermatophagoides pteronyssinus), for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. Odactra is approved for use in individuals 5 through 65 years of age.
02/28/24
Pfizer/BioNTech, Moderna, and Novavax COVID-19 vaccines (Omicron variant XBB.1.5) – CDC recommends an additional vaccine dose in 65 years and older
February 28, 2024 - The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously that another dose of one of the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines should be given to individuals 65 years of age and older.
02/27/24
Brassica Pharma – Recall of eye ointment products
February 26, 2024 - Brassica Pharma announced a consumer level recall of multiple lots of eye ointment products (see chart below) because of potential lack of sterility noted during an inspection conducted by the FDA.
07/30/24
B. Braun Medical – Recall of sodium chloride injection
July 24, 2024 - B. Braun Medical announced a consumer level recall of two lots of sodium chloride 0.9% injection due to the potential for particulate matter and leakage.
08/01/24
Corlanor® (ivabradine) – First-time generic
July 15, 2024 - Ingenus, Camber, and Zydus launched AB-rated generic versions of Amgen’s Corlanor (ivabradine) tablets.
01/06/25
Motegrity® (prucalopride) – First-time generic
January 2, 2025 - ANI Pharmaceuticals launched an AB-rated generic version of Takeda’s Motegrity (prucalopride) tablets.
06/28/25
Gamifant® (emapalumab-lzsg) – New indication
June 28, 2025 - Sobi announced the FDA approval of Gamifant (emapalumab-lzsg), for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic juvenile idiopathic arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
12/12/25
RxNews - December 12, 2025
Breyanzi® (lisocabtagene maraleucel) – New indication<br>Jaypirca® (pirtobrutinib) – Expanded indication, accelerated approval converted to traditional approval<br>Adzenys XR-ODT® (amphetamine) – First-time generic<br>Cipro HC® (ciprofloxacin/hydrocortisone) – First-time generic<br>
07/03/24
Chewtadzy (tadalafil) – New drug approval
June 28, 2024 - The FDA approved ANI Pharmaceuticals’ Chewtadzy (tadalafil) chewable tablets, for the treatment of erectile dysfunction (ED) in adult males; treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult males; and treatment of ED and the signs and symptoms of BPH (ED/BPH) in adult males.
07/29/24
Erzofri®™ (paliperidone palmitate) – New drug approval
July 28, 2024 - Luye Pharma announced the FDA approval of Erzofri (paliperidone palmitate), for the treatment of schizophrenia in adults; and for the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
04/25/24
Ojemda™ (tovorafenib) – New orphan drug approval
April 23, 2024 - The FDA announced the approval of Day One Pharmaceuticals’ Ojemda (tovorafenib), for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
01/16/26
RxNews - January 16, 2026
Cerezyme® (imiglucerase) – Expanded indication<br>Zycubo® (copper histidinate) – New orphan drug approval<br>Glucagon-like peptide-1 receptor agonists – FDA requests removal of suicidal behavior and ideation warning
04/30/24
Otezla® (apremilast) – Expanded indication
April 25, 2024 - The FDA approved Amgen’s Otezla (apremilast), for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
11/27/24
Rapiblyk (landiolol) – New drug approval
November 22, 2024 - The FDA approved AOP Orphan Pharmaceuticals’ Rapiblyk (landiolol), for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.
01/30/26
RxNews - January 30, 2026
Nexplanon® (etonogestrel) – Expanded indication<br> Filkri® (filgrastim-laha) – New biosimilar approval<br>Integra Lifesciences – Recall of MediHoney® wound and burn products<br>ViiV Healthcare Company – Discontinuation of Selzentry® (maraviroc) 20 mg/mL oral solution kit<br>Glaukos Corporation – Discontinuation of Photrexa® (riboflavin 5-phosphate) cross-linking kit
10/14/24
Bimzelx® (bimekizumab-bkzx) – New device approvals
October 14, 2024 - UCB announced the FDA approval of a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx).
03/20/24
Spevigo® (spesolimab-sbzo) – Expanded indication
March 19, 2024 - Boehringer Ingelheim announced the FDA approval of Spevigo (spesolimab-sbzo), for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
06/27/24
RSV vaccines – CDC updates RSV vaccination recommendations
June 26, 2024 - The CDC updated its recommendations for the use of respiratory syncytial virus vaccines in people ages 60 years and older. For this upcoming RSV season, the CDC now recommends everyone ages 75 and older receive the RSV vaccine; and people ages 60 to 74 who are at increased risk of severe RSV, meaning they have certain chronic medical conditions, such as lung or heart disease, or they live in nursing homes, receive the RSV vaccine.
03/19/24
Xhance® (fluticasone propionate) – New indication
March 15, 2024 - OptiNose announced the FDA approval of Xhance (fluticasone propionate), for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.
06/07/24
Rytelo™ (imetelstat) – New orphan drug approval
June 6, 2024 - The FDA announced the approval of Geron’s Rytelo (imetelstat), for the treatment of adult patients with low-to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
12/09/24
Imfinzi® (durvalumab) – New indication
December 5, 2024, - AstraZeneca announced the FDA approval of Imfinzi (durvalumab), as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
09/05/25
RxNews - September 5, 2025
Bildyos® (denosumab-nxxp) – New biosimilar approval<br>Bilprevda® (denosumab-nxxp) – New biosimilar approval<br>Camcevi ETM® (leuprolide) – New formulation approval<br>Comirnaty® (COVID-19 vaccine, mRNA) – New vaccine approval<br>Leqembi® (lecanemab-irmb) – New formulation approval, updated drug monitoring<br>mNEXSPIKE® (COVID-19 vaccine, mRNA) – New vaccine approval<br>Nuvaxovid™ (COVID-19 vaccine, adjuvanted) – New vaccine approval<br>Spikevax® (COVID-19 vaccine, mRNA) – New vaccine approval<br> Wayrilz™ (rilzabrutinib) – New orphan drug approval<br>Unichem – Recall of cyclobenzaprine tablets<br> Saxenda® (liraglutide) – First-time generic<br>Tracleer® (bosentan) tablets for oral suspension – First-time generic
02/13/24
Alrex® (loteprednol) – First-time generic
February 9, 2024 - Armas launched an AB-rated generic version of Bausch and Lomb’s Alrex (loteprednol) 0.2% ophthalmic suspension.
09/23/24
ACAM2000™ (smallpox and mpox (vaccinia) vaccine, live) – New indication
August 29, 2024 - Emergent BioSolutions announced the FDA approval of ACAM2000 (smallpox and mpox (vaccinia) vaccine, live), for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox (previously called monkeypox) infection.
03/31/25
Medicare drug coverage and your rights
Download the current CMS pharmacy notices.
11/20/24
Kebilidi (eladocagene exuparvovec-tneq) – New orphan drug approval
November 14, 2024 - The FDA announced the approval of PTC Therapeutics’ Kebilidi (eladocagene exuparvovec-tneq), for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency.
08/06/25
Ajovy® (fremanezumab-vfrm) – New indication
August 6, 2025 -Teva announced the FDA approval of Ajovy (fremanezumab-vfrm), for the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.
04/17/24
Retevmo® (selpercatinib) – New formulation approval
April 10, 2024 - The FDA approved a new oral tablet formulation of Eli Lilly’s Retevmo (selpercatinib).
08/19/24
Imfinzi® (durvalumab) – New indication
August 16, 2024 - AstraZeneca announced the FDA approval of Imfinzi (durvalumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by Imfinzi continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
02/03/25
Avtozma® (tocilizumab-anoh) – New biosimilar approval
January 30, 2025 - Celltrion announced the FDA approval of Avtozma (tocilizumab-anoh), biosimilar to Genentech’s Actemra® (tocilizumab).
08/22/24
Comirnaty® and Spikevax® (KP.2) 2024 – 2025 vaccines – FDA approval and Emergency Use Authorization
August 22, 2024 - FDA approved Pfizer/BioNTech’s Comirnaty (KP.2) and Moderna’s Spikevax (KP.2) COVID-19 vaccine in individuals 12 years of age and older as a single dose at least 2 months since the last dose of any COVID-19 vaccine.
09/19/25
RxNews - September 19, 2025
Koselugo® (selumetinib) – Expanded indication, new formulation<br> Enbumyst™ (bumetanide) – New drug approval<br> Inlexzo™ (gemcitabine) – New drug approval<br> Zolymbus™ (bimatoprost) – New drug approval<br> Intercept – Withdrawal of Ocaliva® (obeticholic acid)
09/18/24
Keytruda® (pembrolizumab) – New indication
September 18, 2024 - Merck announced the FDA approval of Keytruda (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
01/17/25
Calquence® (acalabrutinib) – New indication, accelerated approval converted to traditional approval
January 17, 2025 - AstraZeneca announced the FDA approval of Calquence (acalabrutinib), in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
02/16/24
Xolair® (omalizumab) – New indication
February 16, 2024 - Novartis announced the FDA approval of Xolair (omalizumab), for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.
07/01/24
Ahzantive™ (aflibercept-mrbb) – New biosimilar approval
July 1, 2024 - Formycon announced the FDA approval of Ahzantive (aflibercept-mrbb), biosimilar to Regeneron’s Eylea (aflibercept).
03/19/24
Iclusig® (ponatinib) – Expanded indication
March 19, 2024 - Takeda announced the FDA approval of Iclusig (ponatinib), in combination with chemotherapy, for treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
01/02/25
Opdivo Qvantig™ (nivolumab/hyaluronidase-nvhy) – New formulation approval
December 27, 2024 - The FDA announced the approval of Bristol Myers Squibb’s Opdivo Qvantig (nivolumab/hyaluronidase-nvhy), a subcutaneous (SC) formulation of Opdivo® (nivolumab).
12/27/23
Hospira – Recall of sodium bicarbonate and atropine injection products
December 26, 2023 - The FDA announced consumer level recalls of Hospira’s sodium bicarbonate 4.2% injection, sodium bicarbonate 8.4% injection and atropine injection products because of the potential for the presence of glass particulate matter identified during product inspection.
06/11/24
Roche – Recall of Accu-Chek® Guide Meter
May 13, 2024 - Roche announced a user-level recall of some Accu-Chek Guide Kits because they were configured incorrectly and show results in mmol/L rather than in the labeled measuring unit, mg/dL.
06/25/24
American Health Packaging – Recall of potassium chloride extended-release capsules
June 25, 2024 - American Health Packaging announced a consumer level recall of 21 lots of potassium chloride extended-release capsules because they may not dissolve as intended. The brand of the recalled capsules is BluePoint Laboratories.
08/07/24
Voranigo® (vorasidenib) – New orphan drug approval
August 6, 2024 - Servier Pharmaceuticals announced the FDA approval of Voranigo (vorasidenib), for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.
03/04/24
Clobetasol propionate ophthalmic suspension – New drug approval
March 4, 2024 - Formosa Pharmaceuticals and AimMax Therapeutics announced the FDA approval of clobetasol propionate ophthalmic suspension, for the treatment of post-operative inflammation and pain following ocular surgery.
12/05/25
RxNews - December 5, 2025
Imfinzi® (durvalumab) – New indication<br>Itvisma® (onasemnogene abeparvovec-brve) – New orphan drug approval<br>Voyxact® (sibeprenlimab-szsi) – New drug approval<br>Abbott – Recall of FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors<br>Gleostine® (lomustine) – First-time generic<br> Mavenclad® (cladribine) – First-time generic
10/03/25
RxNews - October 3, 2025
Caprelsa® (vandetanib) – Drug update (REMS removal)<br>Evkeeza® (evinacumab-dgnb) – Expanded indication<br>Tremfya® (guselkumab) – Expanded indications<br>Bondlido® (lidocaine) – New drug approval<br>Clotic (clotrimazole) – New drug approval<br>Enoby™ (denosumab-qbde) – New biosimilar approval<br>Inluriyo (imlunestrant) – New drug approval<br>Palsonify™ (paltusotine) – New orphan drug approval<br>Xtrenbo™ (denosumab-qbde) – New biosimilar approval<br>Endometrin® (progesterone) – First-time generic
04/23/24
Dr. Reddy’s – Recall of sapropterin powder for oral solution
April 23, 2024 - Dr. Reddy’s announced a consumer-level recall of six lots of sapropterin powder for oral solution because of powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.
09/20/24
Rybrevant® (amivantamab-vmjw) – New indication
September 19, 2024 - J&J announced the FDA approval of Rybrevant (amivantamab-vmjw), in combination with carboplatin and pemetrexed, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EFGR tyrosine kinase inhibitor (TKI).
09/13/24
Tecentriq Hybreza™ (atezolizumab/hyaluronidase-tqjs) – New subcutaneous formulation approval
September 12, 2024 - Roche announced the FDA approval of Tecentriq Hybreza (atezolizumab/hyaluronidase-tqjs), for all intravenous (IV) indications of Tecentriq® (atezolizumab) approved for adults, including certain types of lung, liver, skin and soft tissue cancer.
09/20/24
FluMist® (influenza vaccine live) – Self-administration approval
September 20, 2024 - The FDA announced the approval of AstraZeneca’s FluMist (influenza vaccine live) intranasal spray, for self- or caregiver-administration.
06/20/24
Augtyro™ (repotrectinib) – New indication
June 13, 2024 - Bristol Myers Squibb announced the FDA approval of Augtyro (repotrectinib), for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy
12/18/24
Veozah® (fezolinetant) – Boxed warning added
December 16, 2024 - The FDA approved a label update to Astellas’ Veozah (fezolinetant), adding a Boxed Warning for the risk of hepatotoxicity.
09/20/18
Submitting an electronic prior authorization to OptumRx
A guide on submitting an electronic prior authorization for health care providers
11/12/24
Aucatzyl® (obecabtagene autoleucel) – New orphan drug approval
November 8, 2024 - The FDA announced the approval of Autolus’ Aucatzyl (obecabtagene autoleucel), for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
06/27/24
Vigafyde™ (vigabatrin) – New orphan drug approval
June 17, 2024 - Pyros Pharmaceuticals announced the FDA approval of Vigafyde (vigabatrin), as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
07/24/25
Sdalmo (amlodipine) – New drug approval
July 24, 2025 - The FDA approved Brillian’s Sdalmo (amlodipine), which may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension, to lower blood pressure in adults and pediatric patients 6 years of age and older and for coronary artery disease (CAD) in adults (chronic stable angina, vasospastic angina [Prinzmetal's or variant angina], and angiographically documented CAD in patients without heart failure or an ejection fraction < 40%).
02/26/24
Rectiv® (nitroglycerin) – First-time generic
February 23, 2024 - Cosette launched an AB-rated generic version of AbbVie’s Rectiv (nitroglycerin) 0.4% rectal ointment.
12/06/24
Skysona™ (elivaldogene autotemcel) – FDA drug safety communication
November 27, 2024 - The FDA announced it is investigating reports of hematologic malignancies associated with the use of Skysona (elivaldogene autotemcel).
05/30/24
Breyanzi® (lisocabtagene maraleucel) – New indication
May 30, 2024 - Bristol Myers Squibb announced the FDA approval of Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
08/02/24
Baxter – Recall of heparin sodium injection
August 1, 2024 - Baxter Healthcare Corporation announced a consumer level recall of one lot of heparin sodium injection because there were issues related to the bacterial endotoxin test specific to this lot number.
08/22/24
Lazcluze™ (lazertinib) – New drug approval, Rybrevant® (amivantamab) – New indication
August 20, 2024 - J&J announced the FDA approval of Lazcluze (lazertinib), in combination with Rybrevant® (amivantamab), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
11/14/16
Reporting a Fraud, Waste, or Abuse Incident
A Network Pharmacy Provider is required to report any suspected or potential FWA to the Administrator.
07/10/24
Zoryve® (roflumilast) – New indication, new strength
July 9, 2024 - Arcutis Biotherapeutics announced the FDA approval of Zoryve (roflumilast), for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.
08/05/24
Fibryga® (fibrinogen [human]) – New indication
July 31, 2024 - The FDA approved Octapharma’s Fibryga (fibrinogen [human]), for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency.
11/21/25
RxNews - November 21, 2025
Epkinly® (epcoritamab-bysp) – New indication, accelerated approval converted to traditional approval<br>Komzifti™ (ziftomenib) – New drug approval<br>Poherdy® (pertuzumab-dpzb) – First time interchangeable biosimilar approval<br>Redemplo® (plozasiran) – New orphan drug approval<br>Tyruko® (natalizumab-sztn) – First-time biosimilar launch<br>Elevidys® (delandistrogene moxeparvovec-rokl) – FDA safety communication
10/24/24
Abrysvo® (respiratory syncytial virus vaccine) – New indication
October 22, 2024 - Pfizer announced the FDA approval of Abrysvo (respiratory syncytial virus [RSV] vaccine), for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.
04/17/24
Xromi (hydroxyurea) – New drug approval
April 4, 2024 - The FDA approved Rare Disease Therapeutics’ Xromi (hydroxyurea), to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years, with sickle cell anemia with recurrent moderate to severe painful crises.
06/20/24
Keytruda® (pembrolizumab) – New indication
June 17, 2024 - Merck announced the FDA approval of Keytruda (pembrolizumab), in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
01/03/24
Reckitt/Mead Johnson Nutrition – Recall of Nutramigen™ Powder
December 31, 2023 - Reckitt/Mead Johnson (MJN) announced a consumer level recall of select batches of Nutramigen Powder, a specialty infant formula for the dietary management of cows milk allergy, due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria.
01/26/24
Haleon – Recall of Robitussin® Honey CF Max products
January 24, 2024 - Haleon announced a consumer level recall of eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level due to microbial contamination.
09/26/25
RxNews - September 26, 2025
Aukelso™ (denosumab-kyqq) – New biosimilar approval<br>Bosaya™ (denosumab-kyqq) – New biosimilar approval<br>Forzinity™ (elamipretide) – New orphan drug approval<br>Keytruda Qlex™ (pembrolizumab/berahyaluronidase alfa-pmph) – New drug approval<br>Subvenite® (lamotrigine) – New drug approval<br>COVID-19, MMRV, and Hepatitis B vaccines – ACIP recommendations<br>Opzelura® (ruxolitinib) – Expanded indication<br>Tremfya® (guselkumab) – Updated dosing<br>Vyjuvek® (beremagene geperpavec-svdt) – Expanded indication<br> Dr. Reddy’s Laboratories – Withdrawal of ropinirole extended-release tablets
05/16/24
Imdelltra<sup>™</sup (tarlatamab-dlle) – New drug approval
May 16, 2024 - Amgen announced the FDA approval of Imdelltra (tarlatamab-dlle), for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
07/19/24
Tyenne® (tocilizumab-aazg) – New biosimilar formulation launch
July 2, 2024 - Fresenius Kabi announced the launch of Tyenne (tocilizumab-aazg) subcutaneous formulation, a biosimilar to Roche’s Actemra (tocilizumab).
09/17/24
Ebglyss™ (lebrikizumab-lbkz) – New drug approval
September 13, 2024 - Eli Lilly announced the FDA approval of Ebglyss (lebrikizumab-lbkz), for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
10/22/24
Selarsdi™ (ustekinumab-aekn) – New indications and formulation approval
October 22, 2024 - Alvotech and Teva announced the FDA approval of Selarsdi (ustekinumab-aekn), biosimilar to Janssen’s Stelara® (ustekinumab), for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) and moderately to severely active ulcerative colitis (UC).
08/05/24
Tecelra® (afamitresgene autoleucel) – New orphan drug approval
August 1, 2024 - Adaptimmune Therapeutics announced the FDA approval of Tecelra (afamitresgene autoleucel), for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the melanoma-associated antigen A4 (MAGE-A4) antigen as determined by FDA-approved or cleared companion diagnostic devices.
12/18/24
Steqeyma® (ustekinumab-stba) – New biosimilar approval
December 18, 2024 - Celltrion announced the FDA approval of Steqeyma (ustekinumab-stba), the 7th biosimilar to Janssen’s Stelara® (ustekinumab).
10/18/24
Trodelvy™ (sacituzumab govitecan-hziy) – Indication withdrawal
October 18, 2024 - Gilead announced plans to voluntarily withdraw the accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
06/07/24
Firdapse® (amifampridine) – Updated dosing
May 30, 2024 - The FDA approved updated dosing for Catalyst Pharmaceuticals’ Firdapse (amifampridine), for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older.
08/11/25
Venofer® (iron sucrose) – First-time generic
August 11, 2025 - Viatris launched an AB-rated generic version of American Regent’s Venofer (iron sucrose) injection.
01/16/24
Keytruda® (pembrolizumab) – Expanded indication
January 12, 2024 - Merck announced the FDA approval of Keytruda (pembrolizumab), in combination with chemoradiotherapy (CRT), for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.
03/26/24
Pemgarda™ (pemivibart) – Emergency use authorization approval
March 22, 2024 - The FDA announced the emergency use authorization (EUA) approval of Invivyd’s Pemgarda (pemivibart), for the preexposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older weighing at least 40 kg):
03/15/24
Livmarli® (maralixibat) – New indication
March 13, 2024 - Mirum Pharmaceuticals announced the FDA approval of Livmarli (maralixibat), for the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC).
02/23/24
Exblifep® (cefepime/enmetazobactam) – New drug approval
February 22, 2024 - The FDA approved Allecra Therapeutics’ Exblifep (cefepime/ enmetazobactam), for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex.
08/08/25
Grifols – Withdrawal of Gamunex®-C (immune globulin [human]) 10% injection
August 8, 2025 - Grifols Therapeutics announced a voluntary, consumer level withdrawal of two lots of Gamunex-C (immune globulin [human]) 10% injection because of an increased rate of allergic/hypersensitivity type reactions.
06/27/24
Ohtuvayre™ (ensifentrine) – New drug approval
June 26, 2024 - Verona Pharma announced the FDA approval of Ohtuvayre (ensifentrine), for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
07/16/24
Endari™ (l-glutamine) – First-time generic
July 15, 2024 - ANI Pharmaceuticals launched an AA-rated generic version of Emmaus Medical’s Endari (l-glutamine) oral powder.
06/05/24
COVID-19 vaccines – VRBPAC makes recommendations for new monovalent vaccine composition
The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) unanimously voted for the 2024-2025 formula of COVID-19 vaccines in the U.S to include a monovalent JN.1-lineage.
07/28/25
Sirturo® (bedaquiline) – Expanded indication
July 28, 2025 - The FDA approved Janssen’s Sirturo (bedaquiline), as part of combination therapy in adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid.
10/24/25
RxNews - October 24, 2025
Gazyva® (obinutuzumab) – New indication<br>Rybelsus® (semaglutide) – New indication<br>Rytary® (carbidopa/levodopa) – First-time authorized brand alternative<br>Tezspire® (tezepelumab) – New indication<br>Xeljanz® (tofacitinib) – Expanded indication<br>Ravicti® (glycerol phenylbutyrate) – First-time generic
11/07/24
Pavblu™ (aflibercept-ayyh) – New biosimilar launch
October 30, 2024 - Amgen launched Pavblu (aflibercept-ayyh), biosimilar to Regeneron’s Eylea® (aflibercept).
04/22/24
Alecensa® (alectinib) – New indication
April 18, 2024 - Genentech announced the FDA approval of Alecensa (alectinib), as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.
02/13/24
Emflaza® (deflazacort) – First-time generic
February 9, 2024 - Aurobindo launched an AB-rated generic version of PTC Therapeutics’ Emflaza (deflazacort) tablets.
02/03/25
Alvogen – Recall of fentanyl transdermal system
January 31, 2025 - Alvogen announced a voluntary, consumer level recall of one lot of fentanyl transdermal system 25 mcg/h because there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
07/30/24
Tezruly™ (terazosin) – New formulation approval
July 29, 2024 - The FDA approved Novitium’s Tezruly (terazosin) oral solution, for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH), and for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure.
01/31/25
Journavx™ (suzetrigine) – New drug approval
January 30, 2025 - The FDA announced the approval of Vertex’s Journavx (suzetrigine), for the treatment of moderate to severe acute pain in adults.
01/05/24
Nascobal® (cyanocobalamin) – First-time generic
December 28, 2023 - Lupin and Padagis launched AB-rated generic versions of Par’s Nascobal (cyanocobalamin) nasal spray.
09/03/24
Novavax COVID-19 vaccine, adjuvanted (2024-2025 formula) – Emergency Use Authorization
August 30, 2024 - The FDA granted emergency use authorization (EUA) for Novavax’s Novavax COVID-19 vaccine, adjuvanted (2024-2025 formula), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
07/25/24
Kisqali® (ribociclib) – Updated indication
July 22, 2024 - The FDA approved Novartis’ Kisqali (ribociclib), for treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or with disease progression following endocrine therapy.
08/08/24
Zurnai™ (nalmefene) – New drug approval
August 7, 2024 - The FDA announced the approval of Purdue Pharma’s Zurnai (nalmefene), for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.
03/04/24
Rybrevant® (amivantamab-vmjw) – New indication, accelerated approval converted to full approval
March 1, 2024 - Johnson & Johnson announced the FDA approval of Rybrevant (amivantamab-vmjw), in combination with carboplatin and pemetrexed, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
01/17/25
Brynovin™ (sitagliptin) – New drug approval
January 16, 2025 - The FDA approved Azurity Pharmaceuticals’ Brynovin (sitagliptin) oral solution, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
03/15/24
Tevimbra® (tislelizumab-jsgr) – New drug approval
March 14, 2024 - BeiGene announced the FDA approval of Tevimbra (tislelizumab-jsgr), as a single agent, for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
03/13/24
Par Pharmaceutical – Recall of treprostinil injection
March 12, 2024 - Par Pharmaceutical announced a consumer-level recall of one lot of treprostinil injection due to the potential for the presence of silicone particulates in the product solution.
02/26/24
Simlandi® (adalimumab-ryvk) – New biosimilar approval
February 24, 2024 - Alvotech and Teva announced the FDA approval of Simlandi (adalimumab-ryvk) citrate-free, high concentration (100 mg/mL) injection, interchangeable and biosimilar to AbbVie’s Humira® (adalimumab).
11/26/25
RxNews - November 26, 2025
Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – Accelerated approval converted to traditional approval<br>Hyrnuo® (sevabertinib) – New orphan drug approval<br>Imdelltra® (tarlatamab-dlle) – Accelerated approval converted to traditional approval<br>Jubereq® (denosumab-desu) – New biosimilar approval<br>Osvyrti™ (denosumab-desu) – New biosimilar approval<br>Adzynma (ADAMTS13, recombinant-krhn) – FDA safety communication<br>Eylea HD® (aflibercept) – New indication, updated dosing<br>Koselugo® (selumetinib) – Expanded indication<br>Keytruda® (pembrolizumab)/Keytruda Qlex™ (pembrolizumab/berahyaluronidase alfa-pmph) plus Padcev® (enfortumab vedotin-ejfv) – New indication
10/01/24
Sandostatin® LAR Depot (octreotide) – First-time generic
October 1, 2024 - Teva launched an AB-rated generic version of Novartis’ Sandostatin LAR Depot (octreotide) intramuscular injection.
02/28/24
Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – Expanded indication
February 26, 2024 - Gilead announced the FDA approval of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
04/29/24
Libervant™ (diazepam) – New drug approval
April 26, 2024 - The FDA approved Aquestive Therapeutics’ Libervant (diazepam) buccal film, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 to 5 years of age.
02/03/25
Symbravo® (meloxicam/rizatriptan) – New drug approval
January 30, 2025 - Axsome Therapeutics announced the FDA approval of Symbravo (meloxicam/rizatriptan), for the acute treatment of migraine with or without aura in adults.
01/23/25
Namzaric® (memantine/donepezil) – First-time generic
January 23, 2025 - Amneal launched an AB-rated generic version of AbbVie’s Namzaric (memantine/donepezil) 14 mg/10 mg and 28 mg/10 mg extended-release capsules.
12/13/24
Ocaliva® (obeticholic acid) – FDA drug safety communication
December 12, 2024 - The FDA announced that they have identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Intercept’s Ocaliva (obeticholic acid) who did not have cirrhosis of the liver.
10/22/24
Medtronic – Recall of MiniMed™ 600 series or 700 series insulin pumps
October 18, 2024 - Medtronic announced a consumer level recall of its MiniMed 600 series or 700 series insulin pumps due to reports of shortened battery life. A comprehensive analysis found that pumps that have been dropped, bumped, or experienced physical impact even once may result in shortened battery life due to damage to internal electrical components.
12/23/24
Alcon – Recall of Systane® eye drops
December 23, 2024, Alcon Laboratories announced a voluntary, consumer level recall of one lot of Systane lubricant eye drops because of foreign material observed inside a sealed single use vial that was determined to be fungal in nature.
09/23/24
Bimzelx® (bimekizumab) – New indications
September 23, 2024 - UCB announced the FDA approval of Bimzelx (bimekizumab), for three new indications – treatment of adult patients with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation or active ankylosing spondylitis.
10/30/24
Scemblix® (asciminib) – New indication
October 29, 2024 - Novartis announced the FDA approval of Scemblix (asciminib), for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
07/31/25
Alhemo® (concizumab-mtci) – Expanded indication
July 31, 2025 - Novo Nordisk announced the FDA approval of Alhemo (concizumab-mtci), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with Hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors; Hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors.
03/25/24
Duvyzat™ (givinostat) – New orphan drug approval
March 21, 2024 - The FDA announced the approval of Italfarmaco’s Duvyzat (givinostat), for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
09/20/24
Miplyffa™ (arimoclomol) – New orphan drug approval
September 20, 2024 - The FDA announced the approval of Zevra Therapeutics’ Miplyffa (arimoclomol), for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older.
10/25/24
OVID-19 vaccines – ACIP recommends additional 2024-2025 vaccine doses for certain groups
October 23, 2024 - The Centers for Disease Control and Prevention’s (CDC) Director endorsed the CDC’s Advisory Committee on Immunization Practice’s (ACIP) recommendation for people 65 years and older and those who are moderately or severely immunocompromised to receive a second dose of 2024 - 2025 COVID-19 vaccine six months after their first dose.
01/21/25
Datroway® (datopotamab deruxtecan-dlnk) – New drug approval
January 17, 2025, Daiichi Sankyo and AstraZeneca announced the FDA approval of Datroway (datopotamab deruxtecan-dlnk), for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
02/19/24
Tagrisso® (osimertinib) – Expanded indication
February 19, 2024 - AstraZeneca announced the FDA approval of Tagrisso (osimertinib), in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
07/02/25
Lynozyfic™ (linvoseltamab-gcpt) – New drug approval
July 2, 2025 - Regeneron announced the FDA approval of Lynozyfic (linvoseltamab-gcpt), for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
11/27/24
Rapiblyk (landiolol) – New drug approval
November 22, 2024 - The FDA approved AOP Orphan Pharmaceuticals’ Rapiblyk (landiolol), for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.
03/13/24
Besponsa™ (inotuzumab ozogamicin) – Updated indication
March 6, 2024 - The FDA approved Pfizer’s Besponsa (inotuzumab ozogamicin), for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.
06/27/24
Glenmark – Recall of potassium chloride extended-release capsules
June 24, 2024 - Glenmark announced a consumer level recall of 114 lots of potassium chloride extended-release capsules because of failed dissolution.
06/23/25
Datroway® (datopotamab deruxtecan-dlnk) – New indication
June 23, 2025 - The FDA announced the approval of AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk), for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
03/11/24
Praluent® (alirocumab) – Expanded indication
March 11, 2024 - Regeneron announced the FDA approval of Praluent (alirocumab), as an adjunct to diet and other low density lipoprotein cholesterol (LDL-C)-lowering therapies in pediatric patients aged 8 years and older with heterozygous familial.
01/09/24
Prolensa® (bromfenac) – First-time generic
January 9, 2024 - Lupin launched an AB-rated generic version of Bausch Health’s Prolensa (bromfenac) ophthalmic 0.07% solution.
03/05/24
Jubbonti® (denosumab-bbdz) – New first-time interchangeable biosimilar approval
March 5, 2024 - The FDA approved Sandoz’s Jubbonti (denosumab-bbdz), biosimilar and interchangeable to Amgen’s Prolia® (denosumab).
10/07/24
Opdivo® (nivolumab) – New indication
October 3, 2024 - Bristol-Myers Squibb announced the FDA approval of Opdivo (nivolumab), for the neoadjuvant treatment of adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, in combination with platinum-doublet chemotherapy followed by single-agent Opdivo as adjuvant treatment after surgery.
01/22/24
Balversa® (erdafitinib) – Updated indication, accelerated approval converted to full approval
January 19, 2024 - Johnson & Johnson announced the full FDA approval of Balversa (erdafitinib), for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
10/31/25
RxNews - October 31, 2025
Revuforj® (revumenib) – New indication<br>Winrevair™ (sotatercept-csrk) – Updated indication <br>Blenrep® (belantamab mafodotin-blmf) – New drug approval <br>Contepo® (fosfomycin) – New drug approval<br>Javadin™ (clonidine) – New drug approval<br>Lynkuet® (elinzanetant) – New drug approval<br>Merck – Discontinuation of Zepatier® (elbasvir/grazoprevir) tablet<br>Premarin® (conjugated estrogens) – First-time generic
04/09/24
Enhertu® (fam-trastuzumab deruxtecan-nxki) – New indication
April 5, 2024 - Daiichi Sankyo and AstraZeneca announced the FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki), for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
06/27/24
Victoza® (liraglutide) – First-time authorized brand alternative
June 24, 2024 - Teva launched an authorized brand alternative of Novo Nordisk’s Victoza (liraglutide) injection.
12/27/23
Hospira – Recall of bleomycin injection
December 22, 2023 - Hospira, a Pfizer company, announced a consumer level recall of one lot of bleomycin for injection, due to a confirmed customer report for the presence of glass particulate within a single vial.
02/15/24
Aurlumyn™ (iloprost) – New orphan drug approval
February 14, 2024 - The FDA announced the approval of Eicos Sciences’ Aurlumyn (iloprost), for the treatment of severe frostbite in adults to reduce the risk of digit amputations.
09/10/24
Filspari® (sparsentan) – Updated indication, accelerated approval converted to full approval
September 5, 2024 - Travere Therapeutics announced the full FDA approval of Filspari (sparsentan), to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
07/31/25
Long-term opioid analgesic use – FDA requires updated prescribing information
July 31, 2025 - The FDA announced it is requiring safety labeling changes for opioid pain medicines to further emphasize and characterize the risks associated with long-term use.
05/07/24
Halaven® (eribulin) – First-time generic
May 7, 2024 - Apotex launched an AP-rated generic version of Eisai’s Halaven (eribulin) injection.
07/10/24
Velphoro® (sucroferric oxyhydroxide) – Expanded indication
July 1, 2024 - The FDA approved Fresenius’ Velphoro (sucroferric oxyhydroxide), for the control of serum phosphorus levels in adults and pediatric patients 9 years of age and older with chronic kidney disease (CKD) on dialysis.
08/19/24
Nexobrid® (anacaulase-bcdb) – Expanded indication
August 15, 2024 - Vericel Corporation announced the FDA approval of Nexobrid (anacaulase-bcdb), for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.
08/29/25
RxNews - August 29, 2025
Repatha® (evolocumab) – Expanded/updated indications<br>Thrombate III® (antithrombin III [human]) – Expanded indication<br>Cyklx™ (articaine) – New drug approval<br>Dawnzera™ (donidalorsen) – New orphan drug approval<br>Eligard® (leuprolide) – First-time authorized brand alternative<br>Ixchiq® (chikungunya vaccine, live) – FDA suspends biologics license
07/15/25
Dificid® (fidaxomicin) – First-time generic
July 15, 2025 - Teva launched an AB-rated generic version of Merck’s Dificid (fidaxomicin) tablets.
09/13/24
Dupixent® (dupilumab) – Expanded indication
September 13, 2024 - Regeneron announced the FDA approval of Dupixent (dupilumab), as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
10/18/24
Lumryz™ (sodium oxybate) – Expanded indication
October 17, 2024 - Avadel Pharmaceuticals announced the FDA approval of Lumryz (sodium oxybate) extended-release oral suspension, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
12/27/23
Insight – Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray
December 22, 2023 - Insight announced a consumer level recall of one lot of Americaine 20% Benzocaine Topical Anesthetic Spray because a third-party lab found that a sample of this lot showed a low level of benzene came from the propellant that sprays the product out of the can. Benzene is not an ingredient in any Americaine products. No other lots of this Americaine product were found to contain benzene.
07/23/24
Epysqli® (eculizumab-aagh) – New biosimilar approval
July 22, 2024 - Samsung Bioepis announced the FDA approval of Epysqli (eculizumab-aagh), biosimilar to AstraZeneca’s Soliris® (eculizumab).
04/17/24
Selarsdi™ (ustekinumab-aekn) – New biosimilar approval
April 16, 2024 - Alvotech and Teva announced the FDA approval of Selarsdi (ustekinumab-aekn), biosimilar to Janssen’s Stelara® (ustekinumab).
03/19/24
Edurant ® (rilpivirine) – Expanded indication and new formulation
March 15, 2024 - The FDA announced the approval of Janssen’s Edurant and Edurant PED (rilpirvirine), in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.
05/20/24
Opuviz<sup>™</sup> (aflibercept-yszy) and Yesafili<sup>™</sup> (aflibercept-jbvf)– New first-time interchangeable biosimilar approvals
May 20, 2024 - The FDA announced the approval of Samsung Bioepis/Biogen’s Opuviz (aflibercept-yszy) and Biocon’s Yesafili (aflibercept-jbvf), biosimilar and interchangeable to Regeneron’s Eylea (aflibercept).
06/20/24
Kevzara® (sarilumab) – New indication
June 11, 2024 - Regeneron and Sanofi announced the FDA approval of Kevzara (sarilumab), for treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh 63 kg or greater
12/17/24
Unloxcyt™ (cosibelimab-ipdl) – New drug approval
December 13, 2024 - Checkpoint Therapeutics announced the FDA approval of Unloxcyt (cosibelimab-ipdl), for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
12/30/24
Tevimbra® (tislelizumab-jsgr) – New indication
December 27, 2024 - BeiGene announced the FDA approval of Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥ 1).
08/12/24
neffy® (epinephrine) – New drug approval
August 9, 2024 - The FDA announced the approval of ARS Pharmaceuticals neffy (epinephrine), for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
03/20/24
Tryvio™ (aprocitentan) – New drug approval
March 20, 2024 - Idorsia announced the FDA approval of Tryvio (aprocitentan), in combination with other antihypertensive drugs, for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other drugs.
03/31/25
Imfinzi® (durvalumab) – New indication
March 31, 2025 - AstraZeneca announced the FDA approval of Imfinzi (durvalumab), in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
08/06/25
Vuity® (pilocarpine) – First-time generic
August 6, 2025 - Amneal launched an AB-rated generic version of AbbVie’s Vuity (pilocarpine) ophthalmic solution.
04/04/24
Risvan® (risperidone) – New drug approval
April 2, 2024 - Rovi announced the FDA approval of Risvan (risperidone), for the treatment of schizophrenia in adults.
05/23/24
Hospira – Recall of buprenorphine injection and labetalol injection
May 21, 2024 - Hospira announced a voluntary user-level recall of two lots of buprenorphine injection and three lots of labetalol injection due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit.
07/28/25
Skytrofa® (lonapegsomatropin-tcgd) – Expanded indication
July 28, 2025 - Ascendis Pharma announced the FDA approval of Skytrofa (lonapegsomatropin-tcgd), for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).
09/26/24
Tagrisso® (osimertinib) – New indication
September 26, 2024, - AstraZeneca announced the FDA approval of Tagrisso (osimertinib), for the treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. This is the first targeted therapy approved for unresectable, stage III disease.
07/29/25
Vyscoxa™ (celecoxib) – New drug approval
July 29, 2025 - The FDA approved Carwin Pharmaceutical’s Vyscoxa (celecoxib) oral suspension in adults for the management of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; in pediatric patients two years of age and older for the management of the signs and symptoms of juvenile rheumatoid arthritis.
03/25/24
Nexletol® (bempedoic acid), Nexlizet® (bempedoic acid/ezetimibe) – New/expanded indications
March 22, 2024 - Esperion announced the FDA approval of Nexletol (bempedoic acid), to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: (1) established cardiovascular disease (CVD), or (2) a high risk for a CVD event but without established CVD.
01/02/24
Udenyca® Onbody™ (pegfilgrastim-cbqv) – New biosimilar approval
December 26, 2023 - Coherus announced the FDA approval of Udenyca Onbody (pegfilgrastim-cbqv), biosimilar to Neulasta® Onpro® (pegfilgrastim) kit.
12/20/24
Gemtesa® (vibegron) – New indication
December 18, 2024 - The FDA approved Sumitomo Pharma’s Gemtesa (vibegron), for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).
10/14/24
Itovebi™ (inavolisib) – New drug approval
October 10, 2024 - The FDA announced the approval of Genentech’s Itovebi (inavolisib), in combination with Ibrance® (palbociclib) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
06/20/24
Yimmugo® (immune globulin intravenous, human - dira) – New drug approval
June 17, 2024 - Grifols announced the FDA approval of Yimmugo (immune globulin intravenous, human - dira), for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.
07/17/20
Prior Authorization Guidelines and Procedures
Your guide to the OptumRx Prior Authorization process
09/18/24
Cimzia® (certolizumab pegol) – New indication
September 13, 2024 - The FDA approved UCB’s Cimzia (certolizumab pegol), for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.
03/04/25
Stoboclo® (denosumab-bmwo) – New biosimilar approval
March 3, 2025, Celltrion announced the FDA approval of Stoboclo (denosumab-bmwo), biosimilar to Amgen’s Prolia® (denosumab).
10/22/24
Vyloy® (zolbetuximab-clzb) – New orphan drug approval
October 18, 2024 - Astellas announced the FDA approval of Vyloy (zolbetuximab-clzb), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.
04/02/24
Voydeya™ (danicopan) – New orphan drug approval
April 1, 2024 - AstraZeneca announced the FDA approval of Voydeya (danicopan), as add-on therapy to Ultomiris® (ravulizumab) or Soliris® (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).
08/12/24
Fabhalta® (iptacopan) – New indication
August 7, 2024 - Novartis announced the FDA approval of Fabhalta (iptacopan), to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.
11/12/24
Danziten (nilotinib) – New drug approval
November 7, 2024 - The FDA approved Azurity Pharmaceuticals’ Danziten (nilotinib) tablets, for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; chronic phase and accelerated phase Ph+ CML resistant or intolerant to prior therapy that included imatinib.
07/07/25
Ekterly® (sebetralstat) – New orphan drug approval
July 7, 2025 - KalVista Pharmaceuticals announced the FDA approval of Ekterly (sebetralstat), for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
01/31/24
Takeda – Withdrawal of Vonvendi® (von Willebrand factor, recombinant)
January 26, 2024 - Takeda announced a consumer level withdrawal of two lots of Vonvendi (von Willebrand factor, recombinant) because of misprinted product labels with an incorrect expiration date.
01/17/24
Casgevy™ (exagamglogene autotemcel) – New orphan indication
January 16, 2024 - Vertex announced the FDA approval of Casgevy (exagamglogene autotemcel), for the treatment of patients aged 12 years and older with transfusion-dependent β-thalassemia (TDT).
06/27/24
Epkinly® (epcoritamab-bysp) – New indication
June 26, 2024 - AbbVie and Genmab announced the FDA approval of Epkinly (epcoritamab-bysp), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
01/28/25
Ozempic® (semaglutide) – New indication
January 28, 2025 - Novo Nordisk announced the FDA approval of Ozempic (semaglutide), to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD).
10/17/25
RxNews - October 17, 2025
Libtayo® (cemiplimab-rwlc) – New indication<br>Olpruva® (sodium phenylbutyrate) – Updated indication<br>Rinvoq® (upadacitinib) – Updated indications<br>Simponi® (golimumab) – Expanded indication<br>Uzedy® (risperidone) – New indication<br>Lasix® Onyu (furosemide) – New drug approval<br>Trividia Health – Recall of Good Neighbor Pharmacy True Metrix® Self-Monitoring Blood glucose meters
02/04/25
Grafapex™ (treosulfan) – New orphan drug approval
December 22, 2024 - Medexus Pharmaceuticals announced the FDA approval of Grafapex (treosulfan), in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
07/03/24
Nypozi™ (filgrastim-txid) – New biosimilar approval
June 28, 2024 - The FDA approved Tanvex’s Nypozi (filgrastim-txid), biosimilar to Amgen’s Neupogen (filgrastim).
04/29/24
Pivya™ (pivmecillinam) – New drug approval
April 24, 2024 - The FDA announced the approval of Utility Therapeutics’ Pivya (pivmecillinam), for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (UTI) caused by susceptible isolates of Escherichia coli (E. coli), Proteus mirabilis, and Staphylococcus saprophyticus.
01/21/25
Spravato® (esketamine) – Expanded indication
January 21, 2025 - J&J announced the FDA approval of Spravato (esketamine), for the treatment of treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant.
01/31/24
Gammagard Liquid® (immune globulin infusion [human] 10% solution) – New indication
January 22, 2024 - Takeda announced the FDA approval of Gammagard Liquid (immune globulin infusion [human] 10% solution), as a therapy to improve neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
04/25/24
Lutathera® (lutetium Lu 177 dotatate) – Expanded indication
April 23, 2024 - Novartis announced the FDA approval of Lutathera (lutetium Lu 177 dotatate), for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
03/04/25
Soliris® (eculizumab) – Expanded indication
February 28, 2025 - The FDA approved AstraZeneca’s Soliris (eculizumab), for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 6 years of age and older who are anti-acetylcholine receptor (AChR) antibody positive.
07/28/25
Sephience™ (sepiapterin) – New orphan drug approval
July 28, 2025 - PTC Therapeutics announced the FDA approval of Sephience (sepiapterin), for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU).
09/04/24
Oxtellar XR® (oxcarbazepine) – First-time generic
September 1, 2024 - Apotex launched an AB-rated generic version of Supernus’ Oxtellar XR (oxcarbazepine) extended-release tablets.
06/20/24
Blincyto® (blinatumomab) – New indication
June 14, 2024 - Amgen announced the FDA approval of Blincyto (blinatumomab), for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older.
07/10/24
Endo – Recall of clonazepam orally disintegrating tablets
July 5, 2024 - Endo announced a consumer level recall of one lot of clonazepam orally disintegrating 0.25 mg tablets because they may have been packaged in a carton labelled as 0.125 mg.
05/31/24
Retevmo® (selpercatinib) – Expanded indications
The FDA approved Eli Lilly’s Retevmo (selpercatinib), for the treatment of adult and pediatric patients 2 years of age and older with Advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. Advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate); Locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
05/02/24
Cyltezo® (adalimumab-adbm) – Correction - high concentration formulation approved as biosimilar, not interchangeable
May 1, 2024 - Boehringer Ingelheim announced the FDA approval of Cyltezo (adalimumab-adbm) citrate-free, high concentration (40 mg/0.4 mL) injection, biosimilar to AbbVie’s Humira® (adalimumab).
03/28/24
Amneal – Recall of vancomycin oral solution
March 27, 2024 - Amneal announced a consumer-level recall of four lots of vancomycin oral solution because some bottles may have been overfilled which can result in a super potent dosing regimen.
03/05/24
Wyost® (denosumab-bbdz) – New first-time interchangeable biosimilar approval
March 5, 2024 - The FDA approved Sandoz’s Wyost (denosumab-bbdz), biosimilar and interchangeable to Amgen’s Xgeva® (denosumab).
12/20/24
Zepbound® (tirzepatide) – New indication
December 20, 2024 - The FDA announced the approval of Eli Lilly’s Zepbound (tirzepatide), in combination with a reduced-calorie diet and increased physical activity, for treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
09/18/24
Bionpharma – Recall of atovaquone oral suspension
September 17, 2024 - Bionpharma announced a consumer level recall of one lot of atovaquone oral suspension because the lot contained Cohnella bacteria.
05/31/24
mRESVIA™ (respiratory syncytial virus vaccine) – New vaccine approval
May 31, 2024 - Moderna announced the FDA approval of mRESVIA (respiratory syncytial virus vaccine), for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
03/25/24
Ultomiris® (ravulizumab-cwvz) – New indication
March 25, 2024 - AstraZeneca announced the FDA approval of Ultomiris (ravulizumab-cwvz), for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
05/20/24
Simlandi® (adalimumab-ryvk) – New biosimilar launch
May 20, 2024 - Alvotech and Teva launched Simlandi (adalimumab-ryvk), an interchangeable biosimilar to AbbVie’s Humira® (adalimumab).
06/17/25
Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) – First-time generic
June 17, 2025 - Mylan/Viatris launched an AB-rated generic version of Gilead/Janssen’s Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets.
05/03/24
Myhibbin (mycophenolate mofetil) – New drug approval
May 1, 2024 - The FDA approved Liqmeds Worldwide’s Myhibbin (mycophenolate mofetil) oral suspension, for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
12/03/24
Jesduvroq® (daprodustat) – Withdrawal from the market
December 19, 2024 - GSK announced the decision to voluntarily withdraw Jesduvroq (daprodustat) from the US marketplace due to business reasons. The withdrawal is not due to any safety or efficacy issues.
07/29/24
Palforzia® (peanut [Arachis hypogaea] allergen powder-dnfp) – Expanded indication
July 25, 2024 - Mirum Pharmaceuticals announced the FDA approval of Livmarli (maralixibat), for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
03/25/24
Opsynvi® (macitentan/tadalafil) – New orphan drug approval
March 25, 2024 - Johnson & Johnson announced the FDA approval of Opsynvi (macitentan/tadalafil), for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class [FC] II-III).
04/09/24
XGen Pharmaceuticals – Recall of cyclophosphamide injection
April 3, 2024 - XGen Pharmaceuticals announced a consumer level recall of two lots of cyclophosphamide injection because there was an error on the Physician’s Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as “20 mg per vial.” This information should read: “20 mg per mL.”
01/22/24
Piqray® (alpelisib) – Expanded indication
January 18, 2024 - The FDA approved Novartis’ Piqray (alpelisib), in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
04/19/24
Tyenne® (tocilizumab-aazg) – First-time biosimilar launch
April 15, 2024 - Fresenius Kabi announced the launch of Tyenne (tocilizumab-aazg) intravenous infusion, a biosimilar to Roche’s Actemra (tocilizumab).
08/01/24
Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – New indication
July 30, 2024 - The FDA announced the approval of Johnson & Johnson’s Darzalex Faspro (daratumumab/hyaluronidase-fihj), for the treatment of adult patients with multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).
12/16/24
Crenessity™ (crinecerfont) – New orphan drug approval
December 13, 2024 - The FDA announced the approval of Neurocrine Biosciences’ Crenessity (crinecerfont), as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
01/31/24
Gralise® (gabapentin) – First-time generic
January 25, 2024 - Zydus launched AB-rated generic versions of Almatica’s Gralise (gabapentin) 300 mg and 600 mg tablets.
09/18/24
Fasenra® (benralizumab) – New indication
September 18, 2024 - AstraZeneca announced the FDA approval of Fasenra (benralizumab), for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
08/22/24
Lucemyra® (lofexidine) – First-time generic
August 21, 2024 - Indoco Remedies launched an AB-rated generic version of US WorldMeds’ Lucemyra (lofexidine) tablets.
01/05/24
Farxiga® (dapagliflozin) – First-time authorized brand alternative
January 3, 2024 - Prasco launched an authorized brand alternative of Astra Zeneca’s Farxiga (dapagliflozin) tablets.
06/20/24
Imfinzi® (durvalumab) – New indication
June 17, 2024 - AstraZeneca announced the FDA approval of Imfinzi (durvalumab), in combination with carboplatin and paclitaxel followed by Imfinzi as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
08/01/24
Abbott– Recall FreeStyle Libre® 3 Sensors
July 31, 2024 - Abbott announced a consumer level recall of three lots of FreeStyle Libre 3 sensors because the sensors may provide incorrect high glucose readings.
05/01/24
Ingrezza® Sprinkle (valbenazine) – New formulation approval
April 30, 2024 - Neurocrine Biosciences announced the FDA approval of Ingrezza Sprinkle (valbenazine) capsules, for the treatment of adults with Tardive dyskinesia or Chorea associated with Huntington’s disease.
12/23/24
Alhemo® (concizumab-mtci) – New orphan drug approval
December 23, 2024, Novo Nordisk announced the FDA approval of Alhemo (concizumab-mtci), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with Hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors, or Hemophilia B (congenital factor IX deficiency) with FIX inhibitors.
02/19/24
Amtagvi™ (lifileucel) – New orphan drug approval
February 16, 2024 - The FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
04/19/24
Fasenra® (benralizumab) – Expanded indication
April 5, 2024 - The FDA approved AstraZeneca’s Fasenra (benralizumab), as add-on maintenance treatment of patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype.
04/02/24
AvKARE– Recall of atovaquone oral suspension
April 1, 2024 - AvKARE announced a consumer level recall of one lot of atovaquone oral suspension because of potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.
11/27/24
Bimzelx® (bimekizumab-bkzx) – New indication
November 20, 2024 - UCB announced the FDA approval of Bimzelx (bimekizumab-bkzx), for the treatment of adults with moderate to severe hidradenitis suppurativa.
06/30/25
Extended-release stimulants for ADHD – FDA warns of weight loss risk in patients < 6 years old
June 30, 2025 - The FDA announced it is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions in patients younger than 6 years taking these medications.
08/05/24
Jemperli (dostarlimab-gxly) – Expanded indication
August 1, 2024 - GSK announced the FDA approval of Jemperli (dostarlimab-gxly), in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC).
03/08/24
Wegovy® (semaglutide) – New indication
March 8, 2024 - The FDA announced the approval of Novo Nordisk’s Wegovy (semaglutide), in combination with a reduced calorie diet and increased physical activity, to reduce the risk of major adverse cardiovascular events (MACE) (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease (CVD) and either obesity or overweight.
07/25/24
Livmarli® (maralixibat) – Expanded indication, new strength
July 25, 2024 - Mirum Pharmaceuticals announced the FDA approval of Livmarli (maralixibat), for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
03/29/24
Vafseo® (vadadustat) – New drug approval
March 27, 2024 - Akebia announced the FDA approval of Vafseo (vadadustat), for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
03/28/24
Ixinity® (coagulation factor IX [recombinant]) – Expanded indication
March 26, 2024 - Medexus Pharma announced the FDA approval of Ixinity (coagulation factor IX [recombinant]), in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management and routine prophylaxis to reduce the frequency of bleeding episodes.
09/30/22
Pharmacy Provider Relations Intake Form
Use this form to submit network rejections, pricing inquiries, and claim payment issues to Pharmacy Provider Relations.
09/04/24
Sprycel® (dasatinib) – First-time generic
September 1, 2024 - Apotex launched an AB-rated generic version of Bristol Myers Squibb’s Sprycel (dasatinib) tablets.
06/11/24
Motpoly XR™ (lacosamide) – New indication
June 7, 2024 - The FDA approved Aucta Pharmaceuticals’ Motpoly XR (lacosamide) extended-release capsules, as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg.
03/01/24
Veklury® (remdesivir) – Expanded indication
February 28, 2024 - The FDA approved Gilead’s Veklury (remdesivir), for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are: (1) hospitalized, or (2) not hospitalized and have mild-to-moderate COVID-19 and, are at high risk for progression to severe COVID-19, including hospitalization or death.
06/24/25
Elevidys® (delandistrogene moxeparvovec-rokl) – FDA safety communication
June 24, 2025 - The FDA announced that the agency has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with Duchenne muscular dystrophy (DMD) with Elevidys (delandistrogene moxeparvovec-rokl).
06/11/24
Iqirvo® (elafibranor) – New orphan drug approval
June 10, 2024 - Ipsen announced the FDA approval of Iqirvo (elafibranor), for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
07/22/25
Entresto® (sacubitril/valsartan) – First-time generic
July 22, 2025 - Novadoz launched MSN’s AB-rated generic version of Novartis’ Entresto (sacubitril/valsartan) tablets. Torrent later launched its generic Entresto on July 24, 2025.
07/29/24
Zunveyl® (benzgalantamine) – New drug approval
July 29, 2024 - Alpha Cognition announced the FDA approval of Zunveyl (benzgalantamine), for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.
02/13/24
Eohilia™ (budesonide) – New orphan drug approval
February 12, 2024 - Takeda announced the FDA approval of Eohilia (budesonide), for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).
05/03/24
Mircera® (methoxy polyethylene glycol-epoetin beta) – Expanded indication
April 30, 2024 - The FDA approved Vifor’s Mircera (methoxy polyethylene glycol-epoetin beta), for the treatment of anemia associated with chronic kidney disease (CKD) in pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.
04/29/24
Rinvoq® (upadacitinib), Rinvoq LQ (upadacitinib) – New formulation approval, New/expanded indications
April 26, 2024 - The FDA approved a new oral solution formulation of Novartis’ Rinvoq (upadacitinib) (brand name Rinvoq LQ).
02/27/24
Thiola EC® (tiopronin) – First-time generic
February 27, 2024 - Torrent launched an AB-rated generic version of Mission Pharmacal’s Thiola EC (tiopronin) delayed-release tablet.
07/09/25
Eprontia® (topiramate) – First-time generic
July 9, 2025 - Ascend launched Alkem’s AB-rated generic version of Azurity’s Eprontia (topiramate) oral solution.
04/22/24
Entyvio® (vedolizumab) – New indication for subcutaneous use
April 19, 2024 - Takeda announced the FDA approval of the subcutaneous (SC) formulation of Entyvio (vedolizumab), for maintenance treatment in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) Entyvio.
01/26/24
Azurity – Recall of Zenzedi® (dextroamphetamine)
January 24, 2024 - Azurity announced a consumer level recall of one lot of Zenzedi (dextroamphetamine) 30 mg tablets because a bottle labeled as Zenzedi contained carbinoxamine tablets.
04/17/24
Entresto® Sprinkle (sacubitril/valsartan) – New formulation approval
April 12, 2024 - The FDA approved Novartis’ Entresto Sprinkle (sacubitril/valsartan), a new oral pellets within capsule formulation of Entresto.
04/23/24
Rezenopy (naloxone) – New drug approval
April 19, 2024 - The FDA approved Summit Biosciences’ Rezenopy (naloxone) nasal spray, for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients.
06/27/24
Skyrizi® (risankizumab-rzaa) – New indication
June 18, 2024 - AbbVie announced the FDA approval of Skyrizi (risankizumab-rzaa), for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
06/21/24
GLP-1 receptor agonist update – Tirzepatide for obstructive sleep apnea
June 21, 2024 - Eli Lilly presented the positive results from the SURMOUNT-OSA Phase 3 trials for tirzepatide for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity at the American Diabetes Association® (ADA) 84th Scientific Sessions.
03/06/24
Tyenne® (tocilizumab-aazg) – New biosimilar approval
March 6, 2024 - Fresenius Kabi announced the FDA approval of Tyenne (tocilizumab-aazg), biosimilar to Genentech’s Actemra (tocilizumab).
01/23/25
Glatiramer acetate – Boxed warning added
January 22, 2025 - The FDA announced that a Boxed Warning for the risk of anaphylaxis will be added to the labels of all glatiramer acetate containing products (e.g., Copaxone®, Glatopa®).
04/04/24
Relyvrio® (sodium phenylbutyrate/taurursodiol) – Drug discontinuation
April 4, 2024 - Amylyx Pharmaceuticals announced that it has started a process with the FDA to voluntarily discontinue the marketing authorization for Relyvrio (sodium phenylbutyrate/taurursodiol) and remove the product from the market based on topline results from the Phase 3 PHOENIX trial.
11/04/24
PreHevBrio® (hepatitis B vaccine [recombinant]) – Discontinuation and withdrawal from the market
October 25, 2024 - VBI Vaccines announced the decision to discontinue and withdraw PreHevBrio (hepatitis B vaccine [recombinant]) due to business reasons. The discontinuation and withdrawal are not due to any safety or efficacy issues.
07/30/25
Atmeksi® (methocarbamol) – New drug approval
July 30, 2025 - The FDA approved Rosemont Pharmaceuticals’ Atmeksi (methocarbamol) oral suspension, as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older.
04/23/24
Anktiva® (nogapendekin alfa inbakicept-pmln) – New drug approval
April 22, 2024 - ImmunityBio announced the FDA approval of Anktiva (nogapendekin alfa inbakicept-pmln), in combination with Bacillus Calmette-Guérin (BCG), for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
02/28/25
Purixan® (mercaptopurine) – First-time generic
February 27, 2025 - Hikma launched an AB-rated generic version of Nova Laboratories’ Purixan (mercaptopurine) oral suspension.
01/24/24
FDA safety update – Prolia® (denosumab)
January 19, 2024 - The FDA announced the addition of a Boxed Warning to the Prolia (denosumab) drug label regarding the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD).
07/09/25
Xarelto® (rivaroxaban) oral suspension – First-time generic
July 9, 2025 - Ascend launched Alkem’s AB-rated generic version of Janssen’s Xarelto (rivaroxaban) oral suspension.
07/02/24
Kisunla™ (donanemab-azbt) – New drug approval
July 2, 2024 - Eli Lilly announced the FDA approval of Kisunla (donanemab-azbt), for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.
07/14/25
Kerendia® (finerenone) – New indication
July 14, 2025 - Bayer announced the FDA approval of Kerendia (finerenone), to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.
05/30/24
Bkemv™ (eculizumab-aeeb) – New first-time interchangeable biosimilar approval
May 28, 2024 - The FDA approved Amgen’s Bkemv (eculizumab-aeeb), biosimilar and interchangeable to AstraZeneca’s Soliris® (eculizumab).
01/02/25
Arixtra® (fondaparinux) – New indication
December 23, 2024 - The FDA approved Mylan’s Arixtra (fondaparinux), for the treatment of venous thromboembolism (VTE) in pediatric patients aged 1 year or older weighing at least 10 kg.
06/20/25
Descovy® (emtricitabine/tenofovir alafenamide), Tybost® (cobicistat) – Updated indications
June 20, 2025 - The FDA approved an updated indication for Gilead’s Descovy (emtricitabine/tenofovir alafenamide), for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor.
03/07/24
Brukinsa® (zanubrutinib) – New indication
March 7, 2024 - BeiGene announced the FDA approval of Brukinsa (zanubrutinib), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.
01/22/20
Specialty Management Access Portal user guide
A guide for health care providers to submit specialty medications used in medical treatment through the Specialty Management Access Portal.
06/26/25
CAR T cell immunotherapies – Updated labeling and elimination of REMS
June 26, 2025 - The FDA approved updated labeling for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies and eliminated the Risk Evaluation and Mitigation Strategies (REMS) program for these products.
03/07/24
Opdivo® (nivolumab) – New indication
March 7, 2024 - Bristol Myers Squibb announced the FDA approval of Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).
07/22/25
Arnuity® Ellipta® (fluticasone furoate) – First-time authorized brand alternative
July 22, 2025 - Prasco launched an authorized brand alternative of GSK’s Arnuity Ellipta (fluticasone furoate) inhaler.
07/29/24
Leqselvi™ (deuruxolitinib) – New drug approval
July 25, 2024 - Sun Pharma announced the FDA approval of Leqselvi (deuruxolitinib), for the treatment of adults with severe alopecia areata.
08/06/25
Modeyso™ (dordaviprone) – New orphan drug approval
August 6, 2025 - The FDA announced the approval of Jazz Pharmaceuticals’ Modeyso (dordaviprone), for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
04/29/24
Beqvez™ (fidanacogene elaparvovec-dzkt) – New orphan drug approval
April 29, 2024 - Pfizer announced the FDA approval of Beqvez (fidanacogene elaparvovec-dzkt), for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and, do not have neutralizing antibodies to adeno-associated virus serotype Rh74var capsid as detected by an FDA-approved test.
07/01/24
Pyzchiva® (ustekinumab-ttwe) – New biosimilar approval
July 1, 2024 - Samsung Bioepis and Sandoz announced the FDA approval of Pyzchiva (ustekinumab-ttwe), biosimilar to Janssen’s Stelara® (ustekinumab).
04/09/24
Dovato (dolutegravir/lamivudine) – Expanded indication
April 8, 2024 - ViiV Healthcare announced the FDA approval of Dovato (dolutegravir/ lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.
07/23/25
Vostally (ramipril) – New drug approval
July 23, 2025 - The FDA approved Rosemont Pharmaceuticals’ Vostally (ramipril) oral solution.
12/26/24
Victoza® (liraglutide) – First-time A-rated generic launch
December 24, 2024 - Hikma launched an AP-rated generic version of Novo Nordisk’s Victoza (liraglutide) injection.
06/27/24
Somatuline® Depot (lanreotide) – First-time generic
May 23, 2024 - Cipla launched an AB-rated generic version of Ipsen’s Somatuline Depot (lanreotide) 120 mg/0.5 mL injection.
01/05/24
Xigduo® XR (dapagliflozin/metformin) – First-time authorized brand alternative
January 3, 2024 - Prasco launched an authorized brand alternative of AstraZeneca’s Xigduo XR (dapagliflozin/metformin) extended-release tablets.
08/12/25
Brinsupri™ (brensocatib) – New drug approval
August 12, 2025 - Insmed announced the FDA approval of Brinsupri (brensocatib), for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
12/26/25
RxNews - December 26, 2025
Jascayd® (nerandomilast) – New indication<br>Recarbrio® (imipenem/cilastatin/relebactam) – Expanded indication<br>Rubraca® (rucaparib) – Updated indication, accelerated approval converted to traditional approval<br>Vraylar® (cariprazine) – Expanded indication, new strengths<br>Exdensur (depemokimab) – New drug approval<br>Fesilty™ (fibrinogen, human - chmt) – New drug approval<br>Lunsumio Velo™ (mosunetuzumab-axgb) – New drug approval<br>Myqorzo™ (aficamten) – New drug approval<br>Rybrevant Faspro™ (amivantamab/hyaluronidase-lpuj) – New drug approval<br>Wegovy® (semaglutide) – New formulation approval<br>MediNatura New Mexico – Recall of ReBoost Nasal Spray and ClearLife Allergy Nasal Spray<br>Andexxa® (coagulation factor Xa [recombinant], inactivated-zhzo) – FDA Safety Communication
07/23/24
Hikma – Recall of acetaminophen injection
July 22, 2024 - Hikma announced a consumer level recall of one lot of acetaminophen injection 1000 mg/100 mL (10 mg/mL) due to the potential presence of a bag labelled dexmedetomidine injection (400 mcg/100 mL) inside the overwrap that is labeled acetaminophen injection, 1000 mg/100 mL, (10 mg/mL).
12/27/19
Medication therapy management portal user guide
Guide for pharmacies providing MTM services to members.
07/11/25
Spikevax® (COVID-19 vaccine, mRNA) – Expanded indication
July 11, 2025 - Moderna announced the FDA approval of Spikevax (COVID-19 vaccine, mRNA), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals who are: 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
06/27/24
Piasky (crovalimab-akkz) – New orphan drug approval
June 20, 2024 - The FDA approved Genentech’s Piasky (crovalimab-akkz), for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
01/30/24
Keytruda® (pembrolizumab) – Updated indication, accelerated approval converted to full approval
January 25, 2024 - The FDA granted full approval of Merck’s Keytruda (pembrolizumab), for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
02/23/24
Udenyca® Onbody™ (pegfilgrastim-cbqv) – First-time biosimilar launch
February 24, 2024 - Alvotech and Teva announced the FDA approval of Simlandi (adalimumab-ryvk) citrate-free, high concentration (100 mg/mL) injection, interchangeable and biosimilar to AbbVie’s Humira® (adalimumab).
06/27/24
Sofdra™ (sofpironium) – New drug approval
June 20, 2024 - Botanix announced the FDA approval of Sofdra (sofpironium), treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
11/13/24
Mitsubishi Tanabe – Discontinuation of Radicava® (edaravone) intravenous
October 10, 2024 - Mitsubishi Tanabe announced a business decision to discontinue intravenous (IV) Radicava (edaravone). Radicava IV is not being discontinued for reasons of safety or effectiveness.
09/23/24
Gilead – Recall of Veklury® (remdesivir) injection
September 23, 2024 - Gilead announced a voluntary, consumer level recall of one lot of Veklury (remdesivir) injection because of the presence of a glass particle in the vial.
08/15/24
Niktimvo™ (axatilimab-csfr) – New orphan drug approval
August 14, 2024,- Incyte and Syndax Pharmaceuticals announced the FDA approval of Niktimvo (axatilimab-csfr), for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
12/20/24
Imcivree® (setmelanotide) – Expanded indication
December 20, 2024 - Rhythm Pharmaceuticals announced the FDA approval of Imcivree (setmelanotide), to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to: (1) Bardet-Biedl syndrome (BBS) and (2) pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
12/19/25
RxNews - December 19, 2025
Addyi® (flibanserin) – Expanded indication<br>Akeega® (niraparib/abiraterone) – New indication<br>Blujepa (gepotidacin) – New indication<br>Enhertu® (fam-trastuzumab deruxtecan-nxki) – Expanded indication<br>Omisirge® (omidubicel-onlv) – New orphan indication<br>Orladeyo® (berotralstat) – Expanded indication, new formulation<br>Uplizna® (inebilizumab-cdon) – New indication<br>Cardamyst™ (etripamil) – New drug approval<br>Daybue® Stix (trofinetide) – New formulation approval<br>Lerochol™ (lerodalcibep-liga) – New drug approval<br>Nuzolvence® (zoliflodacin) – New drug approval<br>Waskyra (etuvetidigene autotemcel) – New orphan drug approval<br>MediNatura New Mexico – Recall of ReBoost Nasal spray
06/27/24
Elevidys® (delandistrogene moxeparvovec-rokl) – Accelerated approval converted to traditional approval, expanded indication
June 20, 2024 - The FDA announced the traditional approval of Sarepta’s Elevidys (delandistrogene moxeparvovec-rokl), for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age who are ambulatory and have a confirmed mutation in the DMD gene.
07/23/25
Otezla® (apremilast) – Expanded indication
July 23, 2025 - The FDA approved Amgen’s Otezla (apremilast), for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis.
03/27/24
Winrevair™ (sotatercept) – New orphan drug approval
March 26, 2024 - Merck announced the FDA approval of Winrevair (sotatercept-csrk), for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.
04/30/24
EstroGel® (estradiol) – First-time generic
April 25, 2024 - Solaris launched an AB-rated generic version of Ascend Therapeutics’ EstroGel (estradiol) 0.06% transdermal gel.
08/29/24
Pavblu™ (aflibercept-ayyh) – New biosimilar approval
August 23, 2024 - The FDA approved Amgen’s Pavblu (aflibercept-ayyh), biosimilar to Regeneron’s Eylea® (aflibercept).
10/28/24
Orlynvah™ (sulopenem etzadroxil/probenecid) – New drug approval
October 25, 2024 - Iterum Therapeutics announced the FDA approval of Orlynvah (sulopenem etzadroxil/probenecid), for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
05/30/24
Sagent – Recall of docetaxel injection
May 21, 2024 - Hospira announced a voluntary user-level recall of two lots of buprenorphine injection and three lots of labetalol injection due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit.
12/20/24
Invokana® (canagliflozin), Invokamet/Invokamet® XR (canagliflozin/metformin) – Expanded indication
December 18, 2024 - The FDA approved Janssen’s Invokana (canagliflozin) and Invokamet/Invokamet XR (canagliflozin/metformin), as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
06/20/24
Farxiga® (dapagliflozin), Xigduo® XR (dapagliflozin/metformin) – Expanded indication
June 12, 2024 - AstraZeneca announced the FDA approval of Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin/metformin), as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
10/30/24
Stendra® (avanafil) – First-time generic
October 29, 2024 - Camber launched an AB-rated generic version of Petros’ Stendra (avanafil) tablets.
08/13/24
Yorvipath® (palopegteriparatide) – New orphan drug approval
August 12, 2024 - Ascendis Pharma announced the FDA approval of Yorvipath (palopegteriparatide), for the treatment of hypoparathyroidism in adults.
05/23/24
Breyanzi® (lisocabtagene maraleucel) – New indication
May 15, 2024 - Bristol Myers Squibb announced the FDA approval of Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.
09/13/24
Tremfya® (guselkumab) – New indication
September 11, 2024 - J&J announced the FDA approval of Tremfya (guselkumab), for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
04/30/24
Xolremdi™ (mavorixafor) – New orphan drug approval
April 29, 2024 - The FDA announced the approval of X4 Pharmaceuticals’ Xolremdi (mavorixafor), in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.
01/22/24
Korlym® (mifepristone) – First-time generic
January 19, 2024 - Teva launched an AB-rated generic version of Corcept Therapeutics’ Korlym (mifepristone) 300 mg tablets.
06/27/24
COVID-19 vaccines – ACIP makes recommendations for 2024-2025 vaccine administration
June 27, 2024 - The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) unanimously voted for 2024 – 2025 COVID-19 vaccines as authorized or approved by the FDA in persons ≥ 6 months of age.
01/17/25
Omvoh® (mirikizumab-mrkz) – New indication
January 15, 2025 - Eli Lilly announced the FDA approval of Omvoh (mirikizumab-mrkz), for the treatment of moderately to severely active Crohn’s disease (CD) in adults.
07/02/25
Zegfrovy® (sunvozertinib) – New drug approval
July 2, 2025 - The FDA announced the approval of Dizal Pharmaceuticals’ Zegfrovy (sunvozertinib), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
08/08/24
Crexont® (carbidopa/levodopa) – New drug approval
August 8, 2024 - Amneal Pharmaceuticals announced the FDA approval of Crexont (carbidopa/levodopa), for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.
08/13/24
Nemluvio® (nemolizumab-ilto) – New drug approval
August 13, 2024 - Galderma announced the FDA approval of Nemluvio (nemolizumab-ilto), for the treatment of adults with prurigo nodularis.
07/17/25
Dexcom – Recall of Dexcom G6 and G7 receivers
July 17, 2025 - Dexcom announced a recall of its Dexcom G6 and G7 glucose monitoring receivers because a problem with the speaker may cause it to fail to make an alert sound when blood sugar is dangerously low or high.
08/15/24
Livdelzi® (seladelpar) – New orphan drug approval
August 14, 2024 - Gilead announced the FDA approval of Livdelzi (seladelpar), for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
02/13/24
BromSite® (bromfenac) – First-time generic
February 13, 2024 - Lupin launched an AB-rated generic version of Sun’s BromSite (bromfenac) 0.075% ophthalmic solution.
02/06/26
RxNews - February 6, 2026
Darzalex Faspro® (daratumumab and hyaluronidase-fihj) – Expanded indication<br>Yuvezzi™ (carbachol/brimonidine tartrate) – New drug approval
08/07/25
Skysona® (elivaldogene autotemcel) – Updated labeling
August 7, 2025 - The FDA approved several labeling changes for Skysona (elivaldogene autotemcel) due to new safety information on the increased risk of hematologic malignancy.
12/06/24
Bizengri® (zenocutuzumab-zbco) – New orphan drug approval
December 4, 2024 - Merus announced the FDA approval of Bizengri (zenocutuzumab-zbco), for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy and advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.
11/27/24
Imkeldi (imatinib) – New drug approval
November 22, 2024 - The FDA approved Shorla Oncology’s Imkeldi (imatinib) oral solution.
12/03/24
Yesintek™ (ustekinumab-kfce) – New biosimilar approval
December 1, 2024 - Biocon announced the FDA approval of Yesintek (ustekinumab-kfce), biosimilar to Janssen’s Stelara® (ustekinumab).
09/26/24
Pfizer – Withdrawal of Oxbryta® (voxelotor) tablets
September 25, 2024 - Pfizer announced a voluntary withdrawal of all lots of Oxbryta (voxelotor) tablets because the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.
06/27/24
Krazati® (adagrasib) – New indication
June 21, 2024 - The FDA approved Bristol Myers Squibb’s Krazati (adagrasib), in combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
03/19/24
Breyanzi® (lisocabtagene maraleucel) – New indication
March 14, 2024 - Bristol Myers Squibb announced the FDA approval of Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy including, a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
06/10/24
Arexvy® (respiratory syncytial virus vaccine) – Expanded indication
June 7, 2024 - GSK announced the FDA approval of Arexvy (respiratory syncytial virus vaccine), for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.
01/02/26
RxNews - January 2, 2026
Accrufer ® (ferric maltol) – Expanded indication<br>Furoscix® (furosemide) – Expanded indication<br>Mounjaro® (tirzepatide) – Expanded indication<br>Zynyz® (retifanlimab-dlwr) – Accelerated approval converted to traditional approval<br>Aqvesme™ (mitapivat) – New orphan drug approval<br>Boncresa® (denosumab-mobz) – New biosimilar approval<br>Oziltus® (denosumab-mobz) – New biosimilar approval<br>Yartemlea® (narsoplimab-wuug) – New orphan drug approval
08/22/25
RxNews - August 22, 2025
Actemra® (tocilizumab) – Expanded indication<br>Wegovy® (semaglutide) – New indication<br>Papzimeos™ (zopapogene imadenovec-drba) – New drug approval<br>Tonmya™ (cyclobenzaprine) – New drug approval<br>Celltrion – Recall of Steqeyma® (ustekinumab-stba) injection
07/31/25
Vizz™ (aceclidine) – New drug approval
July 31, 2025 - LENZ Therapeutics announced the FDA approval of Vizz (aceclidine), for the treatment of presbyopia in adults.
04/02/24
Vemlidy® (tenofovir alafenamide) – New indication
March 28, 2024 - Gilead announced the FDA approval of Vemlidy (tenofovir alafenamide), for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.
03/20/25
Auryxia® (ferric citrate) – First-time authorized generic alternative
March 20, 2025 - Mylan/Viatris launched an authorized generic alternative of Keryx Biopharmaceuticals/Akebia Therapeutics’ Auryxia (ferric citrate) tablets.
06/27/24
Vyvgart® Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) – New indication
June 21, 2024 - argenx announced the FDA approval of Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc), for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
10/01/24
Otulfi™ (ustekinumab-aauz) – New biosimilar approval
September 30, 2024 - Formycon and Fresenius Kabi announced the FDA approval of Otulfi (ustekinumab-aauz), biosimilar to Janssen’s Stelara® (ustekinumab).
06/20/24
COVID-19 vaccines – FDA makes recommendations for new monovalent vaccine composition for 2024-2025
June 13, 2024 - The FDA advised that the preferred JN.1-lineage for the COVID-19 vaccines (2024 - 2025 formula) is the KP.2 strain, if feasible.
01/28/25
Enhertu® (trastuzumab deruxtecan) – Expanded indication
January 27, 2025 - AstraZeneca and Daiichi Sankyo announced the FDA approval of Enhertu (trastuzumab deruxtecan), for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
10/14/24
Hympavzi™ (marstacimab-hncq) – New orphan drug approval
October 11, 2024 - Pfizer announced the FDA approval of Hympavzi (marstacimab-hncq), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with Hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or Hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.
07/28/25
Empaveli® (pegcetacoplan) – New indication
July 28, 2025 - Apellis announced the FDA approval of Empaveli (pegcetacoplan), for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria.
01/16/24
Hyqvia® (immune globulin infusion 10% [human] with recombinant human hyaluronidase) – New orphan indication
January 16, 2024 - Takeda announced the FDA approval of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase), for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults.
07/30/25
Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – Expanded indication
July 30, 2025 - The FDA approved Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir.
10/18/24
Vyalev™ (foscarbidopa/foslevodopa) – New drug approval
October 17, 2024 - AbbVie announced the FDA approval of Vyalev (foscarbidopa/ foslevodopa), for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).
01/09/24
Zelsuvmi™ (berdazimer) – New drug approval
January 5, 2024 - Ligand Pharmaceuticals announced the FDA approval of Zelsuvmi (berdazimer), for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients one year of age and older.
07/24/25
Anzupgo® (delgocitinib) – New drug approval
July 24, 2025 - LEO Pharma announced the FDA approval of Anzupgo (delgocitinib), for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.
07/15/25
Kirsty™ (insulin aspart-xjhz) – New first-time interchangeable biosimilar approval
July 15, 2025 - The FDA approved Biocon Biologics’ Kirsty (insulin aspart-xjhz), biosimilar and interchangeable to Novo Nordisk’s Novolog® (insulin aspart).
09/18/24
Kisqali® (ribociclib) – New indication
September 17, 2024 - Novartis announced the FDA approval of Kisqali (ribociclib), in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
08/13/24
Furoscix® (furosemide) – Expanded indication
August 12, 2024 - scPharmaceuticals announced the FDA approval of Furoscix (furosemide), for the treatment of congestion due to fluid overload in adult patients with chronic heart failure.
11/14/25
RxNews - November 14, 2025
Caplyta® (lumateperone) – New indication<br>Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – New indication<br>Linzess® (linaclotide) – Expanded indication<br>Fresenius Kabi – Recall of famotidine injection<br>Grifols – Withdrawal of Gammaked® (immune globulin [human]) 10% injection<br>Bristol Myers Squibb – Discontinuation of Evotaz® (atazanavir/cobicistat) tablets<br>Eli Lilly – Discontinuation of Reyvow® (lasmiditan) tablets<br>Menopausal hormone therapies – FDA requests labeling changes for safety information
11/14/16
FWA Required Training for Health Care Professionals
Required training and fraud, waste and abuse (FWA) attestation for network pharmacies.
03/14/24
Rezdiffra™ (resmetirom) – New drug approval
March 14, 2024 - Madrigal Pharmaceuticals announced the FDA approval of Rezdiffra (resmetirom), in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
04/30/24
Hercessi™ (trastuzumab-strf) – New biosimilar approval
November 4, 2024 - Journey Medical announced the FDA approval of Emrosi (minocycline), to treat inflammatory lesions (papules and pustules) of rosacea in adults.
03/06/24
B. Braun Medical– Recall of potassium chloride for injection
March 6, 2024 - B. Braun Medical announced a consumer-level recall of two lots of potassium chloride for injection due to potential for fluid leakage. The leakage is originating from pinholes within the characters on the label of the IV bag.
08/08/25
Hernexeos® (zongertinib) – New drug approval
August 8, 2025 - The FDA announced the approval of Boehringer Ingelheim’s Hernexeos (zongertinib), for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
11/13/24
Emrosi™ (minocycline) – New drug approval
November 4, 2024 - Journey Medical announced the FDA approval of Emrosi (minocycline), to treat inflammatory lesions (papules and pustules) of rosacea in adults.
12/23/24
Alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor) – New orphan drug approval
December 20, 2024 - Vertex announced the FDA approval of Alyftrek (vanzacaftor/ tezacaftor/deutivacaftor), for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
12/23/24
Trikafta® (elexacaftor/tezacaftor/ivacaftor; ivacaftor) – Updated label, boxed warning added
December 20, 2024 - Vertex announced the FDA approval of the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to Trikafta based on clinical and/or in vitro data.
12/26/24
Astellas – Recall of Astagraf XL® and Prograf® capsules
December 24, 2024 - Astellas announced a voluntary, consumer level recall of one lot of Astagraf XL (tacrolimus) extended-release capsules and one lot of Prograf (tacrolimus) capsules because some bottles may contain empty capsules.
04/04/24
Fanapt® (iloperidone) – New indication
April 2, 2024 - Vanda Pharmaceuticals announced the FDA approval of Fanapt (iloperidone), for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
12/20/24
Braftovi® (encorafenib) – New indication
December 20, 2024, - Pfizer announced the FDA approval of Braftovi (encorafenib), in combination with Erbitux® (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin), for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.
09/23/24
Sarclisa® (isatuximab-irfc) – New indication
September 20, 2024 - Sanofi announced the FDA approval of Sarclisa (isatuximab-irfc), in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
12/20/24
Tryngolza™ (olezarsen) – New orphan drug approval
December 19, 2024 - Ionis Pharmaceuticals announced the FDA approval of Tryngolza (olezarsen), as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
06/27/24
Wakix® (pitolisant) – Expanded indication
June 24, 2024 - Harmony Biosciences announced the FDA approval of Wakix (pitolisant), for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.
11/27/24
Attruby™ (acoramidis) – New orphan drug approval
November 22, 2024 - BridgeBio Pharma announced the FDA approval of Attruby (acoramidis), for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
01/01/26
2026 OptumRx United Healthcare Community and State (Processing Plans with Other Patient Responsibility Billing for COB Claims)
04/29/24
Vijoice® (alpelisib) – New formulation approval
April 24, 2024 - The FDA approved Novartis’ Vijoice (alpelisib) oral granules, for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.
12/19/24
Ryoncil® (remestemcel-L-rknd) – New orphan drug approval
December 18, 2024 - The FDA announced the approval of Mesoblast’s Ryoncil (remestemcel-L-rknd), for the treatment of steroid refractory acute graft versus host disease (SR- aGvHD) in pediatric patients 2 months of age and older.
05/14/18
Long term care pharmacy attestation form
Use this form to enter your attestation to the CMS requirement.
07/25/25
Doptelet ® (avatrombopag) – Expanded indication, new formulation
July 25, 2025 - Sobi announced the FDA approval of Doptelet (avatrombopag), for the treatment of thrombocytopenia in pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
05/30/24
Onyda™ XR (clonidine) – New drug approval
May 24, 2024 - The FDA approved Tris Pharma’s Onyda XR (clonidine) extended-release oral suspension, for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.
12/19/24
Ensacove™ (ensartinib) – New drug approval
December 18, 2024 - The FDA announced the approval of Xcovery’s Ensacove (ensartinib), for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
07/19/24
Endo – Expanded recall of clonazepam orally disintegrating tablets (ODT)
July 16, 2024 - Endo announced a consumer level recall of one lot of clonazepam 0.25 mg ODT which may also appear as clonazepam 0.125 mg ODT. The recall is expanded to include the 0.125 mg strength. The recall was first announced on July 5, 2024.
08/19/24
Protonix® I.V. (pantoprazole) – Expanded indication
August 12, 2024 - The FDA approved Pfizer’s Protonix I.V. (pantoprazole), for treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older.
02/13/26
RxNews - February 13, 2026
Ozempic® (semaglutide) tablets – New formulation approval<br>Quiofic™ (folic acid) – New drug approval<br>Vykoura™ (leucovorin) – New drug approval
02/20/26
RxNews - February 20, 2026
Keytruda® (pembrolizumab), Keytruda Qlex™ (pembrolizumab/berahyaluronidase alfa-pmph) – New indication <br>Hormone replacement therapy – FDA approves removal of boxed warnings<br>Teflaro® (ceftaroline fosamil) – First-time generic
02/27/26
RxNews - February 27, 2026
Leqvio® (inclisiran) – Expanded/new indications<br>Wakix® (pitolisant) – Expanded indication<br>Adquey™ (difamilast) – New drug approval<br>Avopef™ (etoposide) – New drug approval<br>Bysanti™ (milsaperidone) – New drug approval
03/06/26
RxNews - March 6, 2026
Dupixent® (dupilumab) – New indication<br>Hernexeos® (zongertinib) – Expanded indication<br>Palynziq® (pegvaliase-pqpz) – Expanded indication<br>RizaFilm™ (rizatriptan) – Expanded indication, new strength<br>Sogroya® (somapacitan-beco) – New indications<br>Braftovi® (encorafenib) – Accelerated approval converted to traditional approval<br>Desmoda™ (desmopressin) – New drug approval<br>Favlyxa™ (fluorouracil) – New drug approval<br>Loargys® (pegzilarginase-nbln) – New orphan drug approval<br>Nucynta® (tapentadol) – First-time authorized brand alternative<br>Yuviwel® (navepegritide) – New orphan drug approval<br>Cardinal Health – Recall of Webcol™ large alcohol prep pads<br>Briviact® (brivaracetam) – First-time generic<br>Edurant® (rilpivirine) – First-time generic<br>Pomalyst® (pomalidomide) – First-time generic
OptumRx Georgia Provider Information
10/10/25
Optum Rx Managed Care Pharmacy Residency
A postgraduate managed care pharmacy residency program
12/30/25
M3P claims submission training video
This video provides an overview of the Medicare Prescription Payment Plan. It includes guidance for pharmacies on claims processing, message codes, common errors and best practices to support patients effectively.
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