September 19, 2025
Clinical Updates
Koselugo® (selumetinib) – Expanded indication, new formulation
September 10, 2025 - The FDA approved AstraZeneca’s Koselugo (selumetinib), for the treatment of pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Drug Approvals
Enbumyst™ (bumetanide) – New drug approval
September 15, 2025 - Corstasis Therapeutics announced the FDA approval of Enbumyst (bumetanide), for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults.
Drug Approvals
Inlexzo™ (gemcitabine) – New drug approval
September 9, 2025 - J&J announced the FDA approval of Inlexzo (gemcitabine), for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
Drug Approvals
Zolymbus™ (bimatoprost) – New drug approval
September 9, 2025 - The FDA approved Thea Pharma’s Zolymbus (bimatoprost) ophthalmic gel 0.01%, for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Drug Recalls - Availability
Intercept – Withdrawal of Ocaliva® (obeticholic acid)
September 11, 2025 - Intercept announced the voluntary withdrawal of Ocaliva (obeticholic acid) tablets following a request from the Food and Drug Administration (FDA) due to safety concerns.