RxNews®

November 6, 2025 - J&J announced the FDA approval of Caplyta (lumateperone), as adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.

November 6, 2025 - J&J announced the FDA approval of Darzalex Faspro (daratumumab/ hyaluronidase-fihj), as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.

November 4, 2025 - The FDA approved AbbVie’s Linzess (linaclotide), for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older.

November 7, 2025 - Fresenius Kabi announced a voluntary, consumer level recall of three lots of famotidine injection 20 mg per 2 mL because of out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.

October 28, 2025 - Grifols Therapeutics announced a voluntary, consumer level withdrawal of one lot of Gammaked (immune globulin [human]) 10% injection because of an increased rate of allergic/hypersensitivity type reactions.

November 3, 2025 - Bristol Myers Squibb announced a business decision to discontinue Evotaz (atazanavir/cobicistat) tablets. Evotaz is not being discontinued for reasons of safety or effectiveness.

November 3, 2025 - Eli Lilly announced a business decision to discontinue Reyvow (lasmiditan) tablets. Reyvow is not being discontinued for reasons of safety or effectiveness.

November 10, 2025 - The FDA announced it informed application holders of menopausal hormone therapies (MHT), also commonly referred to as hormone replacement therapy (HRT), about requested labeling changes aimed to better clarify the benefit/risk considerations for these medications.