Capricor says FDA may not convene expert panel for cell therapy

Capricor says FDA may not convene expert panel for cell therapy

Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration may not seek its outside experts' advice when deciding on the company's cell therapy for a heart condition associated with Duchenne muscular dystrophy.

Regulatory Update on Capricor’s Deramiocel for Duchenne

Capricor Therapeutics, which received early funding from CureDuchenne, has indicated that the FDA has decided that an Advisory Committee meeting is not warranted at this time.  Capricor’s Biologics License Application (BLA) remains under Priority Review with PDUFA target action date of August 31, 2025Read the full press release HEREThe post Regulatory Update on Capricor’s Deramiocel for Duchenne appeared first on CureDuchenne.