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- FDA advisory panels for Capricor and Replimune highlight need for rare-disease specialist inputRecent FDA advisory committee meetings reviewing therapies from Capricor Therapeutics and Replimune produced markedly different outcomes, underscoring how the agency’s reliance on specialist input…
- Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapiesIndustry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…