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Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request
When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...
Al Arabiya English9h
Gene Therapy Maker Sarepta Tells Fda It Won't Halt Shipments Despite Patient Deaths
Drugmaker Sarepta Therapeutics said late Friday it will not comply with a request from the Food and Drug Administration to ...
Sarepta tells FDA it won’t halt shipments despite patient deaths
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Sarepta: Despite Restructuring, Downgrading To Sell After Latest Developments
The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm ...
Investor's Business Daily on MSN1d
The FDA Will Reportedly Ask Sarepta To Stop Selling Elevidys. Shares Plummet.
Sarepta stock crashed Friday on reports the FDA will ask the biotech company to stop shipments of its approved gene therapy, ...
Sarepta's Setback Deepens With Another Gene Therapy Fatality
Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene ...
Exclusive-US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics to voluntarily stop all shipments of its ...
STAT1d
Patient dies in Sarepta gene therapy trial, adding to safety concerns
A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...
Sarepta Therapeutics Stock Tumbles on Report of Third Death in Clinical Trial
Shares of Sarepta Therapeutics plummeted Friday following a report that a third patient has died during a clinical trial for ...