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BioWorld - Saturday, July 4, 2026
Home » complete response letters

Articles Tagged with ''complete response letters''

FDA’s change of heart

Sarepta’s Vyondys 53 wins a surprise accelerated approval

Dec. 13, 2019
By Lee Landenberger
In August the FDA was skeptical about Sarepta Therapeutics Inc.’s injectable Vyondys 53 (golodirsen), but that changed swiftly Friday with the agency’s accelerated approval for the Duchenne muscular dystrophy (DMD) follow-on therapy, the first treatment specifically for this subtype.
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Assertio stock continues downward slide after CRL

Oct. 22, 2019
By Lee Landenberger
The complete response letter (CRL) received by Assertio Therapeutics Inc.'s development partner, West Therapeutic Development LLC, regarding its NDA for cosyntropin (synthetic adrenocorticotropic hormone, ACTH) knocked Assertio's stock back 28% on Monday.
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