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- FDA grants three-month extension for Capricor’s Duchenne therapy deramiocel, sets new action date Nov 22The U.S. Food and Drug Administration has given Capricor Therapeutics a three‑month extension to review additional data for its Duchenne muscular dystrophy cell therapy, deramiocel. The agency has…
- Regenxbio faces second FDA clinical hold, delaying Hunter syndrome gene therapy filingRegenxbio announced that its gene therapy for Hunter syndrome has received a second clinical hold from the FDA this year. The company said it no longer expects to submit an NDA or seek approval in…