source
- FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy reviewThe FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
- Deloitte urges advanced therapy makers to adopt AI-driven digital staff to overcome operational bandwidth limitsAdvanced therapy manufacturers are confronting an operational bottleneck as their pipelines expand rapidly. More than a thousand advanced therapies are in development and the U.S. patient pool is e…