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- FDA advisory panel votes 9-3 against approval of Capricor’s Duchenne muscular dystrophy therapy deramiocelThe FDA Cellular, Tissue, and Gene Therapies Advisory Committee focused heavily on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, describing the data as very fragile. Committee…
- Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launchesKyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…