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 ...
The Sarepta Mugging and Drug Innovation
The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.
InvestorsHub on MSN6d
Sarepta Shares Drop as FDA Suspends Gene Therapy Trials for Muscular Dystrophy
Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...
FDA opens probe into mysterious death linked to gene therapy
The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...
Sarepta Stock Keeps Sliding as Company Rejects FDA Call to Withdraw Drug
Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...
BioSpace5d
Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
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 Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug
Sarepta Therapeutics' (SRPT) stock continued to sink Monday, down about 5% in early trade, following a rough end to last week ...
Fierce Pharma6d
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...
BioSpace4d
Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries
Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...
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 ...