STAT+: Capricor Therapeutics forges ahead with FDA on Duchenne drug, despite political tumult
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The Food and Drug Administration is nearly halfway through a review of Capricor Therapeutics\u2019 cell therapy for Duchenne muscular dystrophy. Even with the tumult inside the agency, interactions between the company and the agency staff have been unaffected, according to the company\u2019s chief executive.<\/p>\n
\u201cThe information requests have been flowing on a regular basis and follow-up has been rapid and efficient,\u201d CEO Linda Marb\u00e1n told me during a phone call Friday. \u201cThe review continues to go really well.\u201d<\/p>\n
While there have been reports from other drugmakers about possible interruptions with FDA matters<\/a> due to staff layoffs and the ouster of top officials, Capricor \u201chasn\u2019t noticed any difference,\u201d Marb\u00e1n told me.\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n