RX Professionals Resources and Support

04/05/24

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.

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09/23/24

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.

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10/24/24

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.

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04/22/24

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.

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02/28/24

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.

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09/23/24

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.

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03/13/24

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.

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01/22/24

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.

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11/27/24

November 20, 2024 - UCB announced the FDA approval of Bimzelx (bimekizumab-bkzx), for the treatment of adults with moderate to severe hidradenitis suppurativa.

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07/25/24

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).

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04/09/24

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.

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03/19/24

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.

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12/20/24

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.

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04/09/24

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.

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09/10/24

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.

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12/20/24

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).

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01/31/24

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).

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09/18/24

September 18, 2024 - AstraZeneca announced the FDA approval of Fasenra (benralizumab), for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

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01/05/24

January 3, 2024 - Prasco launched an authorized brand alternative of Astra Zeneca’s Farxiga (dapagliflozin) tablets.

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04/19/24

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.

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04/22/24

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.

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01/28/25

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.

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04/04/24

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.

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09/27/24

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.

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01/26/24

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).

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02/28/24

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.

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10/25/24

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.

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09/13/24

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).

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09/18/24

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.

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04/09/24

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.

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01/17/25

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).

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01/17/24

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).

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05/23/24

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.

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11/27/24

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.

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03/05/24

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.

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08/19/24

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.

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08/22/24

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.

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02/16/24

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.

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06/20/24

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

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05/30/24

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.

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08/05/24

July 31, 2024 - The FDA approved Octapharma’s Fibryga (fibrinogen [human]), for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency.

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06/20/24

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.

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06/07/24

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.

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06/05/24

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.

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06/20/24

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

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03/31/25

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).

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08/12/24

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.

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06/27/24

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.

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06/20/24

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.

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12/20/24

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.

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06/20/24

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).

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01/02/25

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.

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01/05/24

January 3, 2024 - Prasco launched an authorized brand alternative of AstraZeneca’s Xigduo XR (dapagliflozin/metformin) extended-release tablets.

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06/20/24

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.

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06/27/24

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.

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06/10/24

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.

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06/20/24

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.

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08/13/24

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.

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08/05/24

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.

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07/19/24

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.

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06/27/24

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.

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07/25/24

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.

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02/19/24

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.

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06/27/24

June 24, 2024 - Teva launched an authorized brand alternative of Novo Nordisk’s Victoza (liraglutide) injection.

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07/10/24

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.

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08/19/24

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.

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05/31/24

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.

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07/29/24

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).

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08/01/24

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).

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08/05/24

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).

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03/08/24

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.

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06/11/24

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.

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06/27/24

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.

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06/21/24

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.

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03/07/24

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.

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06/27/24

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.

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06/27/24

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).

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06/27/24

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.

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08/19/24

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.

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09/04/24

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-]).

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12/17/24

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.

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03/20/24

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.

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03/19/24

March 15, 2024 - OptiNose announced the FDA approval of Xhance (fluticasone propionate), for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

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09/20/24

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).

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10/22/24

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).

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10/18/24

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.

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03/26/24

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):

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03/04/24

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.

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10/30/24

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).

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03/11/24

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.

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12/30/24

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).

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09/26/24

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.

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01/21/25

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.

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03/04/25

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.

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03/25/24

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.

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01/22/24

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.

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03/01/24

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.

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09/13/24

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).

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04/02/24

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.

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12/23/24

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.

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09/23/24

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).

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01/17/25

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.

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01/07/22

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.

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02/15/24

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.

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12/16/24

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.

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03/04/25

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.

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04/30/24

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.

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09/03/24

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.

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10/18/24

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.

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03/25/24

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.

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01/28/25

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).

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04/25/24

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.

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05/03/24

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.

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03/07/24

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).

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01/17/25

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.

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12/09/24

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).

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09/18/24

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).

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03/19/24

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).

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01/16/24

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.

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03/15/24

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).

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03/28/24

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.

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01/30/24

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.

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12/20/24

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.

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12/20/24

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.

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09/18/24

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.

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09/26/24

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.

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01/02/24

December 26, 2023 - Coherus announced the FDA approval of Udenyca Onbody (pegfilgrastim-cbqv), biosimilar to Neulasta® Onpro® (pegfilgrastim) kit.

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12/23/24

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.

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02/19/24

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.

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04/23/24

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.

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12/23/24

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.

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10/14/24

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).

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02/03/25

January 30, 2025 - Celltrion announced the FDA approval of Avtozma (tocilizumab-anoh), biosimilar to Genentech’s Actemra® (tocilizumab).

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11/12/24

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).

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02/15/24

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.

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04/29/24

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.

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11/27/24

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.

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09/27/24

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.

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03/04/24

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.

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01/17/25

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.

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12/16/24

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).

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05/30/24

May 28, 2024 - The FDA approved Amgen’s Bkemv (eculizumab-aeeb), biosimilar and interchangeable to AstraZeneca’s Soliris® (eculizumab).

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12/06/24

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.

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07/10/24

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.

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09/20/24

September 20, 2024 - The FDA announced the approval of AstraZeneca’s FluMist (influenza vaccine live) intranasal spray, for self- or caregiver-administration.

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02/23/24

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.

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02/13/24

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).

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04/17/24

April 12, 2024 - The FDA approved Novartis’ Entresto Sprinkle (sacubitril/valsartan), a new oral pellets within capsule formulation of Entresto.

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11/13/24

November 4, 2024 - Journey Medical announced the FDA approval of Emrosi (minocycline), to treat inflammatory lesions (papules and pustules) of rosacea in adults.

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12/19/24

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.

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10/14/24

October 10, 2024 - Accord announced the FDA approval of Imuldosa (ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab).

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11/20/24

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.

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01/31/25

January 30, 2025 - The FDA announced the approval of Vertex’s Journavx (suzetrigine), for the treatment of moderate to severe acute pain in adults.

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03/05/24

March 5, 2024 - The FDA approved Sandoz’s Jubbonti (denosumab-bbdz), biosimilar and interchangeable to Amgen’s Prolia® (denosumab).

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10/14/24

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.

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05/01/24

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.

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11/20/24

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.

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04/04/24

April 2, 2024 - Rovi announced the FDA approval of Risvan (risperidone), for the treatment of schizophrenia in adults.

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04/29/24

April 26, 2024 - The FDA approved a new oral solution formulation of Novartis’ Rinvoq (upadacitinib) (brand name Rinvoq LQ).

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04/23/24

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.

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03/14/24

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).

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12/19/24

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.

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09/01/24

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.

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03/04/24

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.

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03/19/24

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).

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04/29/24

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.

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09/20/24

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.

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05/03/24

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.

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03/04/25

March 3, 2025 - Celltrion announced the FDA approval of Osenvelt (denosumab-bmwo), biosimilar to Amgen’s Xgeva® (denosumab).

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04/25/24

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.

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10/07/24

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.

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05/20/24

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).

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03/25/24

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).

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10/28/24

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.

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09/17/24

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.

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03/25/24

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.

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01/21/25

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.

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03/19/24

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.

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11/12/24

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.

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05/02/24

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).

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05/16/24

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.

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02/04/25

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).

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11/27/24

November 22, 2024 - The FDA approved Shorla Oncology’s Imkeldi (imatinib) oral solution.

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10/14/24

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.

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01/16/24

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.

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04/30/24

November 4, 2024 - Journey Medical announced the FDA approval of Emrosi (minocycline), to treat inflammatory lesions (papules and pustules) of rosacea in adults.

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04/17/24

April 10, 2024 - The FDA approved a new oral tablet formulation of Eli Lilly’s Retevmo (selpercatinib).

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11/07/24

October 30, 2024 - Amgen launched Pavblu (aflibercept-ayyh), biosimilar to Regeneron’s Eylea® (aflibercept).

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11/27/24

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.

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04/29/24

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.

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08/29/24

August 23, 2024 - The FDA approved Amgen’s Pavblu (aflibercept-ayyh), biosimilar to Regeneron’s Eylea® (aflibercept).

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10/01/24

September 30, 2024 - Formycon and Fresenius Kabi announced the FDA approval of Otulfi (ustekinumab-aauz), biosimilar to Janssen’s Stelara® (ustekinumab).

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12/18/24

December 18, 2024 - Celltrion announced the FDA approval of Steqeyma (ustekinumab-stba), the 7th biosimilar to Janssen’s Stelara® (ustekinumab).

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02/26/24

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).

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02/03/25

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.

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04/17/24

April 16, 2024 - Alvotech and Teva announced the FDA approval of Selarsdi (ustekinumab-aekn), biosimilar to Janssen’s Stelara® (ustekinumab).

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03/04/25

March 3, 2025, Celltrion announced the FDA approval of Stoboclo (denosumab-bmwo), biosimilar to Amgen’s Prolia® (denosumab).

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05/20/24

May 20, 2024 - Alvotech and Teva launched Simlandi (adalimumab-ryvk), an interchangeable biosimilar to AbbVie’s Humira® (adalimumab).

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04/17/24

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.

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10/22/24

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.

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03/05/24

March 5, 2024 - The FDA approved Sandoz’s Wyost (denosumab-bbdz), biosimilar and interchangeable to Amgen’s Xgeva® (denosumab).

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03/27/24

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.

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04/30/24

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.

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12/03/24

December 1, 2024 - Biocon announced the FDA approval of Yesintek (ustekinumab-kfce), biosimilar to Janssen’s Stelara® (ustekinumab).

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10/18/24

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).

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01/09/24

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.

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06/07/24

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).

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07/30/24

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.

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07/01/24

July 1, 2024 - Samsung Bioepis and Sandoz announced the FDA approval of Pyzchiva (ustekinumab-ttwe), biosimilar to Janssen’s Stelara® (ustekinumab).

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06/27/24

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.

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06/27/24

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.

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08/13/24

August 12, 2024 - Ascendis Pharma announced the FDA approval of Yorvipath (palopegteriparatide), for the treatment of hypoparathyroidism in adults.

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06/20/24

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.

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04/04/24

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.

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11/27/24

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.

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07/03/24

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.

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07/01/24

July 1, 2024 - Formycon announced the FDA approval of Ahzantive (aflibercept-mrbb), biosimilar to Regeneron’s Eylea (aflibercept).

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08/08/24

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.

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12/17/24

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.

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04/02/24

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).

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04/19/24

April 15, 2024 - Fresenius Kabi announced the launch of Tyenne (tocilizumab-aazg) intravenous infusion, a biosimilar to Roche’s Actemra (tocilizumab).

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03/29/24

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.

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02/23/24

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).

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04/29/24

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.

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08/12/24

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.

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08/22/24

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.

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08/12/24

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.

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05/31/24

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.

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07/29/24

July 25, 2024 - Sun Pharma announced the FDA approval of Leqselvi (deuruxolitinib), for the treatment of adults with severe alopecia areata.

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08/15/24

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.

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08/13/24

August 12, 2024, Sandoz announced the FDA approval of Enzeevu (aflibercept-abzv), biosimilar to Regeneron’s Eylea® (aflibercept).

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07/29/24

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.

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07/23/24

July 22, 2024 - Samsung Bioepis announced the FDA approval of Epysqli (eculizumab-aagh), biosimilar to AstraZeneca’s Soliris® (eculizumab).

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06/11/24

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.

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07/02/24

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.

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06/27/24

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.

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01/02/25

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).

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06/27/24

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.

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07/03/24

June 28, 2024 - The FDA approved Tanvex’s Nypozi (filgrastim-txid), biosimilar to Amgen’s Neupogen (filgrastim).

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08/15/24

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.

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08/13/24

August 13, 2024 - Galderma announced the FDA approval of Nemluvio (nemolizumab-ilto), for the treatment of adults with prurigo nodularis.

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05/30/24

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.

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09/13/24

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.

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08/05/24

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.

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03/15/24

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.

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03/20/24

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.

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03/06/24

March 6, 2024 - Fresenius Kabi announced the FDA approval of Tyenne (tocilizumab-aazg), biosimilar to Genentech’s Actemra (tocilizumab).

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12/20/24

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).

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08/07/24

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.

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06/27/24

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.

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07/19/24

July 2, 2024 - Fresenius Kabi announced the launch of Tyenne (tocilizumab-aazg) subcutaneous formulation, a biosimilar to Roche’s Actemra (tocilizumab).

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08/08/24

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.

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06/20/24

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.

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07/29/24

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.

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06/11/24

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.

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03/13/24

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.

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12/23/24

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.

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03/28/24

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.

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01/26/24

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.

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09/23/24

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.

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01/23/25

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.

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01/31/24

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.

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04/04/24

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.

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11/04/24

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.

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11/13/24

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.

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09/26/24

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.

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01/16/24

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.

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07/30/24

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.

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06/25/24

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.

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10/22/24

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.

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06/27/24

June 24, 2024 - Glenmark announced a consumer level recall of 114 lots of potassium chloride extended-release capsules because of failed dissolution.

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01/23/25

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®).

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02/28/25

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).

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12/27/23

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.

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04/23/24

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.

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01/03/24

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.

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01/26/24

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.

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03/06/24

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.

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12/27/23

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.

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12/27/23

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.

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05/23/24

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.

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09/18/24

September 17, 2024 - Bionpharma announced a consumer level recall of one lot of atovaquone oral suspension because the lot contained Cohnella bacteria.

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04/02/24

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.

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12/26/24

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.

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01/16/24

FDA authorizes foreign importation of Bicillin® L-A (penicillin G benzathine)

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12/18/24

December 16, 2024 - The FDA approved a label update to Astellas’ Veozah (fezolinetant), adding a Boxed Warning for the risk of hepatotoxicity.

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12/06/24

November 27, 2024 - The FDA announced it is investigating reports of hematologic malignancies associated with the use of Skysona (elivaldogene autotemcel).

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12/13/24

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.

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12/03/24

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.

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01/24/24

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).

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08/02/24

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.

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07/10/24

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.

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08/01/24

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.

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07/23/24

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).

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05/30/24

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.

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07/19/24

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.

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03/29/24

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.

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05/02/24

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.

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11/20/24

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.

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02/27/24

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.

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02/03/25

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.

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04/09/24

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.”

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02/13/24

February 9, 2024 - Armas launched an AB-rated generic version of Bausch and Lomb’s Alrex (loteprednol) 0.2% ophthalmic suspension.

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02/13/24

February 9, 2024 - Aurobindo launched an AB-rated generic version of PTC Therapeutics’ Emflaza (deflazacort) tablets.

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09/04/24

September 1, 2024 - Apotex launched an AB-rated generic version of Supernus’ Oxtellar XR (oxcarbazepine) extended-release tablets.

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09/04/24

September 1, 2024 - Apotex launched an AB-rated generic version of Bristol Myers Squibb’s Sprycel (dasatinib) tablets.

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02/27/24

February 27, 2024 - Torrent launched an AB-rated generic version of Mission Pharmacal’s Thiola EC (tiopronin) delayed-release tablet.

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02/13/24

February 13, 2024 - Lupin launched an AB-rated generic version of Sun’s BromSite (bromfenac) 0.075% ophthalmic solution.

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05/17/24

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02/14/24

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04/17/24

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06/27/24

May 23, 2024 - Cipla launched an AB-rated generic version of Ipsen’s Somatuline Depot (lanreotide) 120 mg/0.5 mL injection.

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10/16/24

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03/13/24

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08/01/24

July 15, 2024 - Ingenus, Camber, and Zydus launched AB-rated generic versions of Amgen’s Corlanor (ivabradine) tablets.

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07/16/24

July 15, 2024 - ANI Pharmaceuticals launched an AA-rated generic version of Emmaus Medical’s Endari (l-glutamine) oral powder.

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08/22/24

August 21, 2024 - Indoco Remedies launched an AB-rated generic version of US WorldMeds’ Lucemyra (lofexidine) tablets.

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12/26/24

December 24, 2024 - Hikma launched an AP-rated generic version of Novo Nordisk’s Victoza (liraglutide) injection.

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10/30/24

October 29, 2024 - Camber launched an AB-rated generic version of Petros’ Stendra (avanafil) tablets.

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03/20/25

March 20, 2025 - Mylan/Viatris launched an authorized generic alternative of Keryx Biopharmaceuticals/Akebia Therapeutics’ Auryxia (ferric citrate) tablets.

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04/23/24

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.

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02/26/24

February 23, 2024 - Cosette launched an AB-rated generic version of AbbVie’s Rectiv (nitroglycerin) 0.4% rectal ointment.

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01/05/24

December 28, 2023 - Lupin and Padagis launched AB-rated generic versions of Par’s Nascobal (cyanocobalamin) nasal spray.

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10/01/24

October 1, 2024 - Teva launched an AB-rated generic version of Novartis’ Sandostatin LAR Depot (octreotide) intramuscular injection.

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01/09/24

January 9, 2024 - Lupin launched an AB-rated generic version of Bausch Health’s Prolensa (bromfenac) ophthalmic 0.07% solution.

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02/28/25

February 27, 2025 - Hikma launched an AB-rated generic version of Nova Laboratories’ Purixan (mercaptopurine) oral suspension.

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01/17/24

January 16, 2024 - ANI Pharmaceuticals launched an AB-rated generic version of Zyla Life Sciences’ Indocin (indomethacin) oral suspension.

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01/06/25

January 2, 2025 - ANI Pharmaceuticals launched an AB-rated generic version of Takeda’s Motegrity (prucalopride) tablets.

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05/07/24

May 7, 2024 - Apotex launched an AP-rated generic version of Eisai’s Halaven (eribulin) injection.

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01/31/24

January 25, 2024 - Zydus launched AB-rated generic versions of Almatica’s Gralise (gabapentin) 300 mg and 600 mg tablets.

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04/30/24

April 25, 2024 - Solaris launched an AB-rated generic version of Ascend Therapeutics’ EstroGel (estradiol) 0.06% transdermal gel.

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01/22/24

January 19, 2024 - Teva launched an AB-rated generic version of Corcept Therapeutics’ Korlym (mifepristone) 300 mg tablets.

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02/14/24

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05/29/24

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11/15/24

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08/18/24

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05/14/18

Use this form to enter your attestation to the CMS requirement.

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12/05/24

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01/15/25

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06/12/24

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07/11/24

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07/14/24

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12/19/24

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09/12/24

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08/11/22

Guide for pharmacies submitting a MAC appeal form

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09/20/18

A guide on submitting an electronic prior authorization for health care providers

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02/24/23

A guide for network pharmacy providers

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11/11/22

Join the OptumRx network today.

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09/30/22

Use this form to submit network rejections, pricing inquiries, and claim payment issues to Pharmacy Provider Relations.

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01/22/20

A guide for health care providers to submit specialty medications used in medical treatment through the Specialty Management Access Portal.

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03/31/25

Download the current CMS pharmacy notices.

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07/17/20

Your guide to the OptumRx Prior Authorization process

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