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- FDA briefing hints tough road for Capricor and Replimune ahead of advisory committee meetingsThe FDA released briefing documents for upcoming advisory committee meetings concerning Capricor Therapeutics' Duchenne muscular dystrophy cell therapy and Replimune's advanced melanoma candidate.…
- FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocelAn FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…