Sarepta says it won’t pull Duchenne gene therapy, setting up showdown with FDAnews2025-07-19T00:43:48+00:00July 19th, 2025|Endpoints News|
FDA adcomm votes against Otsuka’s Rexulti-Zoloft combo for PTSDnews2025-07-18T20:00:23+00:00July 18th, 2025|Endpoints News|
Peter Marks says Sarepta gene therapy pause ‘makes sense’news2025-07-18T19:05:54+00:00July 18th, 2025|Endpoints News|
FDA rejects expanded label for Roche’s Columvinews2025-07-18T18:17:56+00:00July 18th, 2025|Endpoints News|
FDA will ask Sarepta to stop selling Duchenne treatment, following patient deathsnews2025-07-18T17:20:49+00:00July 18th, 2025|Endpoints News|
FDA adcomm votes against GSK’s Blenrep in multiple myelomanews2025-07-17T18:29:49+00:00July 17th, 2025|Endpoints News|
UroMems Receives Clearance from the FDA and the French ANSM for Initiating Landmark Pivotal Clinical Study of UroActiveÒ Smart Implant to Treat Male Stress Urinary Incontinencenews2025-07-17T14:38:59+00:00July 17th, 2025|Medical Device News Magazine|
South Korean drugmaker gets FDA warning over potential site contaminationnews2025-07-17T13:15:35+00:00July 17th, 2025|Endpoints News|
Wearable maker Whoop to fight FDA over blood pressure trackernews2025-07-16T19:23:19+00:00July 16th, 2025|Endpoints News|
FDA drugs center sees sharp rise in staff departures since Januarynews2025-07-16T19:07:10+00:00July 16th, 2025|Endpoints News|