News

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...

Sarepta Stock Continues to Fall After Patient Death Linked to Investigational Gene Therapy

Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...

Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures

The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.

Sarepta to cut 500 jobs, add black-box warning on gene therapy

Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients ...