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BioWorld - Tuesday, January 27, 2026
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» FDA denies approval for new Sarepta DMD therapy, Vyondys 5
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FDA denies approval for new Sarepta DMD therapy, Vyondys 5
Aug. 21, 2019
By
Michael Fitzhugh
Sarepta Therapeutics Inc. has received a complete response letter (CRL) from the FDA as the agency declined to issue a sought-after accelerated approval for the company's Duchenne muscular dystrophy (DMD) follow-on therapy, Vyondys 53 (golodirsen).
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