News

FDA’s Prasad Exits Following Political Backlash Over Sarepta
Vinay Prasad, a top regulator at the US Food and Drug Administration, ended his short tenure at the agency after conservative ...
Sarepta soars after FDA says some patients can get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
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 ...
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 ...
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 ...
Sarepta Therapeutics Stock Surges as FDA Allows Elevidys Sales to Resume
Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.
STAT4d
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 ...
Fierce Pharma4d
FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...
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 ...
BioSpace4d
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 Therapeutics, Inc. (SRPT): “You Don’t Court Homicide,” Says Jim Cramer
We recently published 11 Stocks That Jim Cramer Recently Talked About. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the ...
Fierce Pharma5d
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 ...