The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...

Sarepta Therapeutics (SRPT) stock is in focus after the US Food and Drug Administration (FDA) asked the company to halt ...

Sarepta Therapeutics Inc has voluntarily paused shipments of Elevidys in the United States. The decision responds to FDA ...

Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...

Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...