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Friday, July 24, 2020

Sarepta gene therapy Fast Track’d for Duchenne muscular dystrophy

July 24, 2020

The FDA designates Sarepta Therapeutics’ (NASDAQ:SRPT) gene transfer therapy SRP-9001 for Fast Track review for the treatment of Duchenne muscular dystrophy (DMD), an Orphan Drug and Rare Pediatric Disease-tagged indication.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

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