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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.
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Vinay Prasad, the top vaccine regulator and chief scientific officer at the Food and Drug Administration (FDA) and a critic of the agency’s COVID-19 policies, has departed after being on the job ...
Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...
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Parents urge FDA to restore gene therapy after distribution pauseA recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
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