FDA Will Ask Sarepta to Halt Gene Therapy Shipments
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The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.
Sarepta Therapeutics announces layoffs of 493 employees, including 80 in Franklin County, amid restructuring efforts and criticism from the FDA.
Shares of Sarepta Therapeutics plummeted Friday following a report that a third patient has died during a clinical trial for one of its medications.
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits seen in trials