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

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

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

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

Medicaid and ACA, the homeless crisis, children's health, 'black box' drug warnings, nutrition and SNAP, maternity care, and more.

The FDA asked Sarepta to pause all U.S. shipments of the DMD gene therapy Elevidys, and the company has agreed after initially refusing.

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.

A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...

A breakthrough in trade talks with the U.S. might win Ishiba a reprieve, but so far there's been scant sign of progress in negotiating away the threat of higher tariffs on Japan's exports to the U.S.

An Anderson family is battling their 3-year-old son’s rare brain-development condition. It’s believed that Beau Hanson has the only known case of CASK disorder in Indiana. Fewer than 20 such cases can ...

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...