News

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 ...
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...
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 ...
Hoodline18h
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.
WCMH Columbus on MSN19h
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 ...
Devdiscourse18h
Sarepta Defies FDA Order Amidst Gene Therapy Controversies
Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...
Sarepta Therapeutics laying off nearly 500 employees, including 80 in Franklin County
Sarepta Therapeutics announced a layoff of 493 employees, including 80 in Franklin County, amid restructuring efforts and ...
Asianet Newsable on MSN1d
FDA Is Reportedly ‘Taking A Hard Look’ To Evaluate Whether Sarepta’s Gene Therapy Elevidys Should Remain On The Market
The growing number of fatalities is raising questions about the future of Sarepta’s therapies and the regulatory path for ...
Reuters25d
FDA investigates patient deaths after treatment with Sarepta's gene ...
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 ...
vornews13h
Sarepta Tells FDA It Won’t Stop Shipments Despite Patient Deaths
Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...
Yahoo Finance25d
Sarepta Viral Vector Gets FDA Platform Technology Designation
Sarepta Therapeutics Inc. (NASDAQ: SRPT) is one of the best mid cap growth stocks to invest in now. Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology ...
AOL26d
FDA investigates patient deaths after treatment with Sarepta's ... - AOL
In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns about the safety and future demand for the treatment. Both boys were non-ambulatory ...