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

Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

Roche Holding AG said on Tuesday it has paused all shipments of muscular disorder gene therapy Elevidys outside the U.S., ...

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

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

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

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...

Sarepta (SRPT) paused shipments of its top-selling gene therapy drug after the US Food and Drug Administration (FDA) raised safety concerns tied to liver toxicity. Yahoo Finance Senior Reporter ...

Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the fourth quarter.

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