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FDA review begins for full approval bids on 2 Duchenne therapies
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FDA review begins for full approval bids on 2 Duchenne therapies
The U.S. Food and Drug Administration (FDA) is expected to decide by Feb. 28, 2027, whether to grant traditional approval to Amondys 45 (casimersen) and Vyondys 53 (golodirsen), two exon-skipping therapies designed to treat certain people with Duchenne muscular dystrophy (DMD). Both medications are currently approved in the U.S. under the FDA’s accelerated approval pathway, which allows a therapy to be made available based on early clinical data…
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