News

Sarepta Changes Course, Agrees to Pause Elevidys Shipments
Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
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 ...
BioPharma Dive6d
Sarepta stops Elevidys shipments after standoff with FDA
Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...
Fierce Pharma3d
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News and ...
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.
Managed Healthcare Executive5d
Sarepta to Pause Shipments of the Gene Therapy Elevidys
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...