RxNews®

February 24, 2026 - Sanofi announced the FDA approval of Dupixent (dupilumab), for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.

February 26, 2026 - The FDA announced the approval of Boehringer Ingelheim’s Hernexeos (zongertinib), for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

February 27, 2026 - BioMarin announced the FDA approval of Palynziq (pegvaliase-pqpz), to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.  

February 26, 2026 - The FDA approved Gensco Pharma’s RizaFilm (rizatriptan) oral film, for the acute treatment of migraine with or without aura in adults and pediatric patients 6 years of age and older.

February 27, 2026 - Novo Nordisk announced the FDA approval of Sogroya (somapacitan-beco), for the treatment of pediatric patients aged 2.5 years and older with short stature born small for gestational age and with no catch-up growth by 2 years of age; growth failure associated with Noonan syndrome; or Idiopathic Short Stature.

February 24, 2026 - The FDA granted traditional (full) approval to Pfizer’s Braftovi (encorafenib), in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

February 25, 2026 - Eton Pharmaceuticals announced the FDA approval of Desmoda (desmopressin), for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. 

February 20, 2026 - The FDA approved Avyxa’s Favlyxa (fluorouracil) injection, for the treatment of adenocarcinoma of the colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma, and pancreatic adenocarcinoma.

February 23, 2026 - Immedica Pharma announced the FDA approval of Loargys (pegzilarginase-nbln), for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with arginase 1 deficiency (ARG1-D), in conjunction with dietary protein restriction.

February 25, 2026 - Hikma launched an authorized brand alternative of Collegium’s Nucynta (tapentadol) tablets.

February 27, 2026 - Ascendis Pharma announced the FDA approval of Yuviwel (navepegritide), to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.

March 2, 2026, Cardinal Health announced a voluntary, consumer-level recall of numerous lots of Webcol large alcohol prep pads because they have been deemed non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

February 24, 2026 - Alkem/Ascend, Novadoz, Pharmaceutical Associates, and Lupin launched AA-rated generic versions of UCB’s Briviact (brivaracetam) oral solution.

March 2, 2026 - Somerset Therapeutics launched an AB-rated generic version of Janssen’s Edurant (rilpivirine) tablets.

March 2, 2026 - Breckenridge/Natco, Camber/Hetero, Aurobindo/Eugia, and Teva launched AB-rated generic versions of Celgene’s Pomalyst (pomalidomide) capsules.