US Food and Drug Administration (FDA)
-
Dr. Reddy’s secures US FDA tentative approval for generic lenacapavir for HIV prevention
The approval follows a pricing agreement announced in September 2025 involving Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy’s.
-
FDA expands Pfizer’s Talzenna-Xtandi combination to earlier-stage metastatic prostate cancer
Talzenna (talazoparib), a PARP inhibitor, is used alongside Xtandi (enzalutamide), an androgen receptor inhibitor, to target cancer through complementary mechanisms.
-
Eli Lilly gains FDA approval for Onswik once-weekly insulin in US diabetes market
The approval is based on Lilly’s QWINT Phase III clinical programme, which evaluated insulin efsitora alfa-gobe in more than 3,400 adults with T2D across four registration studies.
-
FDA approves AbbVie’s Juvmo for adults with Parkinson’s disease in US
The approval gives AbbVie another Parkinson’s product following its acquisition of Cerevel Therapeutics.
-
Daiichi Sankyo, Merck withdraw FDA BLA for lung cancer drug in US
The withdrawal changes the immediate US regulatory path for the ES-SCLC indication, but the ongoing Phase III programme provides the companies with another source of clinical data.
-
Ultragenyx wins FDA approval for Fayuvi gene therapy for Sanfilippo syndrome
Patients have an average lifespan of about 15 years, while an estimated 3,000 to 5,000 people in commercially accessible markets live with the condition.
-
Curium enters radioligand therapy market with FDA approval of Bexlutry
Developed by Curium, Bexlutry is a lutetium-177 dotatate injection that references Novartis’ Lutathera, which is approved to treat gastroenteropancreatic neuroendocrine tumors (GEP NETs).
-
FDA accepts Kowa’s K-911 glaucoma eye drop application for review
Kowa is seeking approval based on results from the pivotal Phase III Mont Blanc and Denali trials.
-
Lundbeck’s Asedebart gains EU Orphan Designation for Cushing’s Syndrome
Cushing’s syndrome of endogenous origin occurs when the body produces excessive amounts of cortisol and other steroid hormones.
-
Priovant launches Lisraya in US following historic FDA approval for dermatomyositis
The decision follows positive results from the Phase III VALOR trial (NCT05437263), which showed that Lisraya improved several measures of dermatomyositis disease activity.