News
Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
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 Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash,
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause ...
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback