News

Rheumatology Advisor9h
Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products
The Food and Drug Administration is investigating Sarepta’s gene therapy products following reports of a third death from acute liver failure.
BioSpace29m
FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would ...
Parents call on FDA for path forward after Duchenne's gene therapy pause | Morning in America
The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
News Nation on MSN7h
Parents urge FDA to restore gene therapy after distribution pause
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
US FDA recommends removal of hold on Sarepta's Elevidys in some patients
The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
STAT1h
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
BioPharma Dive1h
FDA allows Sarepta to resume some Elevidys shipments
The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
BioSpace9h
Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
Sarepta Therapeutics to Lift Pause on Shipments of Duchenne Treatment Elevidys
Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...