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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…
- US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deathsThree recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…