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- Capricor Therapeutics sees stock surge as FDA signals openness to extend review of DMD cell therapyCapricor Therapeutics' CEO Linda Marbán told investors that the FDA is receptive to adding open label extension data to its Biologics License Application for deramiocel, its Duchenne muscular dystr…
- Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidanceIndustry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…