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The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old ...
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
On a conference call, CEO Doug Ingram said the decision to cut 36% of the company's staff and halt several drug programs was ...
Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...
Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location.
FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...