Sarepta Therapeutics Receives Complete Response Letter from FDA
- Posted by ISPE Boston
- On August 22, 2019
Sarepta Therapeutics has announced it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD). The CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in […]
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