Sarepta Therapeutics Inc. has pulled another rabbit out of its hat with the US Food and Drug Administration's approval of Vyondys 53 (golodirsen) for Duchenne Muscular Dystrophy on 12 December.
Sarepta Scores Another Remarkable Approval With Vyondys 53 For Duchenne
Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.
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