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- FDA grants three-month extension for Capricor’s Duchenne therapy deramiocel, sets new action date Nov 22The U.S. Food and Drug Administration has given Capricor Therapeutics a three‑month extension to review additional data for its Duchenne muscular dystrophy cell therapy, deramiocel. The agency has…
- FDA’s new leadership aims to restore reliability, but each application remains judged on its dataThe FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…