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- FDA grants Capricor three-month extension to review DMD cell therapy dataThe U.S. Food and Drug Administration has given Capricor Therapeutics an additional three months to evaluate its Duchenne muscular dystrophy cell therapy after the agency asked for more information…
- Amgen and academic centers discuss FDA pilot to accelerate first-in-human trialsThe U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…