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.
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 ...
TipRanks on MSN1d
FDA investigating death of child who received Sarepta’s Elevidys
The U.S. FDA is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta (SRPT) Therapeutics gene therapy for Duchenne ...
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, ...
GEN - Genetic Engineering and Biotechnology News5h
FDA Probes Death of Brazilian Boy Linked to Sarepta’s Elevidys
The FDA is investigating the death last month of an eight-year-old boy in Brazil who had received Sarepta Therapeutics’ Elevidys® (delandistrogene moxeparvovec-rokl)—though the company and its ...
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 ...
Devdiscourse5d
Sarepta Suspends Gene Therapy Shipments After Tragic Deaths
Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...
STAT16d
FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Southwest Journal9d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...