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The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), ...
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk.
Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...
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Axios on MSNDrugmaker refuses FDA request to pull gene therapy
An unusual public feud between the Food and Drug Administration and a maker of gene therapies for rare diseases could test ...
When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
Sarepta's gene therapy pipeline faces renewed scrutiny after a third patient death and FDA plans for a black box warning on ...
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
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