News

FDA investigates patient deaths after treatment with Sarepta's gene therapy
The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...
MedPage Today on MSN2d
FDA Probes Gene Therapy After Two Deaths
The FDA is investigating the deaths of two boys with Duchenne muscular dystrophy who died soon after being treated with ...
pharmaphorum2d
FDA probing deaths with DMD gene therapy Elevidys
Elevidys has been given full approval to treat ambulatory patients with DMD, with an accelerated approval in non-ambulatory ...
BioSpace2d
FDA Reviews Sarepta’s Elevidys After Second Patient Death
The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the ...
Did The FDA Make A Mistake? Sarepta's Elevidys Approval Under Scrutiny
FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety ...
Second patient death reported with gene therapy for muscular dystrophy
Shares of Sarepta Therapeutics have plunged again after the drugmaker reported a second death in connection with its gene ...
Managed Healthcare Executive10d
Sarepta Stops Shipments of Elevidys For Non-Ambulatory DMD Patients
A second patient with Duchenne muscular dystrophy has died from acute liver failure after receiving the gene therapy Elevidys ...
GlobalData on MSN4d
Sarepta and Roche halt DMD gene therapy’s use in certain patients after second death
Shares in both companies were down following news of the second death, casting fresh safety concerns over Elevidys.
Rheumatology Advisor2d
Second Death Prompts New Safety Initiatives for DMD Gene Therapy Elevidys
Sarepta has issued a safety update regarding Elevidys (delandistrogene moxeparvovec-rokl) following a second reported case of acute liver failure resulting in death.
STAT12d
Sarepta reports second patient death after treatment with Duchenne gene therapy
Sarepta said it was halting shipments of its Duchenne gene therapy for patients who can no longer walk, following the death ...
Sarepta Stock Plunges After Death of Second Patient Receiving Its Gene Therapy
A second patient receiving its experimental gene therapy Elevidys has died from liver failure, raising serious questions on ...
Fierce Pharma1d
FDA investigates patient deaths after treatment with Sarepta's Duchenne gene therapy Elevidys
In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...