When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...

The death of a third patient tied to a Sarepta Therapeutics gene therapy this year sent the company’s shares nosediving 36% Friday, halting the momentum the stock generated just a day earlier after ...

Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...

Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...

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.

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.

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 ...

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.

Sarepta will share the panel's recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance.

The FDA has designated the viral vector rAAVrh74, which Sarepta Therapeutics, Inc. (NASDAQ:SRPT) uses in its gene therapy candidate SRP-9003 for limb-girdle muscular dystrophy type 2E/R4 (LGMD2E ...