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- FDA unveils FY 2027 user fee ratesThe US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. Th…raps · 1d ago↗ source
- FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapyA FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…