Documents give inside view of FDA’s rejection, and surprise approval, of Sarepta Duchenne’s drug

Documents give inside view of FDA’s rejection, and surprise approval, of Sarepta Duchenne’s drug

Despite a strongly critical complete response letter – which the FDA sent in August but did not make public until Tuesday – the drugmaker successfully appealed and won approval for the drug, Vyondys 53, in December, to the surprise of many.

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