FDA staff flags concerns for Capricor's Duchenne heart disease therapy
27/07/2026 13:25
FDA staff flags concerns for Capricor's Duchenne heart disease therapy July 27 (Reuters) - U.S. Food and Drug Administration staff reviewers raised concerns about whether Capricor Therapeutics' CAPR.O cell therapy deramiocel has sufficient evidence of effectiveness for treating cardiomyopathy in Duchenne muscular dystrophy, according to briefing documents released on Monday.
(Reporting by Sahil Pandey and Christy Santhosh in Bengaluru; Editing by Devika Syamnath)