Benzinga.com

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an 8-year-old boy who had received Elevidys, Sarepta Therapeutics Inc.’s ...
Seeking Alpha

Sarepta falls as FDA plans to investigate death of child who received Elevidys

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics (NASDAQ:SRPT) gene therapy for Duchenne ...
BioWorld

Sarepta confronts FDA, won’t stop Elevidys shipments

Sarepta Therapeutics Inc. is declining a U.S. FDA request to voluntarily halt shipping its gene therapy, Elevidys (delandistrogene moxeparvovec), in the U.S. On July 18, Sarepta said had it received ...
BioWorld

Sarepta yields to FDA request, pauses Elevidys shipments

In an about-face, Sarepta Therapeutics Inc. said it would “voluntarily and temporarily” pause all shipments of Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) in the U ...
Eagle-Tribune

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following ...

Silver Spring, Md., Nov. 14, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the ...
Monthly Prescribing Reference

Elevidys Use for Ambulatory DMD Patients May Resume, Says FDA

Following a review of safety data in the ambulatory DMD population, the FDA had recommended the removal of the voluntary hold for these patients. The Food and Drug Administration (FDA) is allowing ...