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- FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in JapanThe U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…
- 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…