News

Sarepta Changes Course, Agrees to Pause Elevidys Shipments
Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat ...
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 ...
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 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 halts Elevidys shipments following FDA pressure
Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.
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Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
FDA to ask Sarepta to stop shipping Duchenne gene therapy
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
Sarepta to pause Elevidys gene therapy shipments in U.S.
Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta ...
Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...
Sarepta stops Elevidys shipments after standoff with FDA
Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" with the regulator.
Sarepta to pause gene therapy Elevidys shipments in US
Sarepta Therapeutics said on Monday that it will pause all shipments of its Elevidys gene therapy in the United States after a muscular dystrophy patient who received a different, experimental ...