News

Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, ...
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...
FDA Says Sarepta Can Resume Gene Therapy in Some Patients
In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
BioSpace2d
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 ...
GEN - Genetic Engineering and Biotechnology News2d
Sarepta to Resume Shipping DMD Gene Therapy to Ambulant Patients
Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...
Fierce Pharma1d
Vinay Prasad departs FDA amid conservative criticism, controversy over Sarepta gene therapy
Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...
Fierce Pharma3d
FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
TipRanks on MSN20h
Sarepta Stock (SRPT) Rallies on FDA Nod for Broader Gene Therapy Use
Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...
FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers
Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.
Becker's Hospital Review2d
Death of 8-year-old not tied to Sarepta gene therapy: FDA
The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...
Rheumatology Advisor3d
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.