News

Roche pauses shipments of Elevidys gene therapy outside US
Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside ...
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
Sarepta to pause Elevidys gene therapy shipments in US
Sarepta Therapeutics said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys with a rare condition called Duchenne muscular dystrophy, who had received the ...
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 liver failure after taking it or a similar treatment.
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.
Roche pauses shipments of Elevidys gene therapy outside the US, Bloomberg News reports
Roche Holding AG paused all shipments of the controversial gene therapy Elevidys, Bloomberg News reported on Tuesday.
Roche Pauses Shipments of Contested Gene Therapy Outside the US
Roche Holding AG paused all shipments of the controversial gene therapy Elevidys following a similar action by the embattled ...