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Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...
Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
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 ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
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 to continue Elevidys shipments despite FDA request to halt
Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...
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Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old ...
Sarepta Therapeutics Stock Plunges After Another Patient Death Is Linked to One of Its Gene Therapies
One of biotech’s highest fliers, Sarepta Therapeutics, lost more than a third of its market value on Friday after executives said that one of its experimental gene-replacement therapies was linked to ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
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Sarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in Columbus
Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location. According to a mass layoff notice filed with the ...
DOJ Asks Court to Unseal Epstein Transcripts, Sarepta Refuses FDA Request, More
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