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FDA changes course on Sarepta's once-rejected muscular dystrophy drug

from STAT News

The Food and Drug Administration reversed its decision on a treatment for Duchenne muscular dystrophy from Sarepta Therapeutics, approving a previously rejected drug without explaining what the problem was in the first place. The therapy, called Vyondys 53, is approved to treat the roughly 8% of Duchenne patients whose disease results from a specific DNA error. more


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