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 ...

The FDA appears to have won its staring contest with Sarepta over shipments of Elevidys, after the company blinked and agreed ...

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

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

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

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

Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and ...

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...

Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...