The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...

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

A Massachusetts biotechnology company is laying off 21 employees in Durham amid a broader restructuring and pressure from federal regulators.

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

Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.

The FDA’s language in its Tuesday communication set the parameter for the investigation around treatment of non-ambulatory patients.

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 ...

Today's biotech news features an FDA probe into the deaths tied to Sarepta's Duchenne drug, rejecting KalVista's drug application, etc.

Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology Designation to the rAAVrh74 viral vector.

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne muscular dystrophy who were treated with Sarepta Therapeutics’ gene therapy ...

The Food and Drug Administration is conducting an investigation following the deaths of two patients treated with Sarepta's gene therapy for Duchenne muscular dystrophy.