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Sarepta Therapeutics Temporarily Halts Elevidys Shipments in Compliance with FDA Requests
Sarepta Therapeutics Inc has voluntarily paused shipments of Elevidys in the United States. The decision responds to FDA requests, allowing the company to finalize the safety labeling process for the product.
Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Sarepta Therapeutics said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys with a rare condition called Duchenne muscular dystrophy, who had received the ...
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
The 51-year-old patient who died had suffered from limb-girdle muscular dystrophy, a group of genetic disorders that cause muscles to weaken and atrophy. Sarepta said Friday that the death occurred in ...
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