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- FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy dataThe U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
- FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programsThe U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…