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FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.
The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
In March, Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy ...
Sarepta (SRPT) Therapeutics shared the following update related to ELEVIDYS, the only approved gene therapy in patients with Duchenne muscular dystrophy. Following the safety update on acute liver ...
Pharma In approving Sarepta's DMD gene therapy, FDA's Peter Marks overruled reviewers' rejection By Zoey Becker Jun 26, 2023 11:35am Peter Marks FDA Sarepta Therapeutics Duchenne muscular ...
WASHINGTON (dpa-AFX) - Sarepta Therapeutics, Inc. (SRPT), Tuesday said that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved Elevidys for the treatment of Duchenne muscular ...
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