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- FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
- 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…