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- FDA pushes back PDUFA date for Capricor's Duchenne therapy to review new dataThe U.S. Food and Drug Administration announced it has extended the PDUFA target date for Capricor Therapeutics' investigational Duchenne muscular dystrophy treatment. The agency said the extensio…
- FDA finalizes guidance on therapeutic equivalence evaluations for ANDAsThe U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applicati…