News

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 ...
BioSpace6h

‘Unprecedented’ FDA Leaks Sow Confusion For Patients, Sarepta and Capricor

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

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 Soars After FDA Says Some Patients Can Get Elevidys

In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...

FDA’s Prasad Exits Following Political Backlash Over Sarepta

Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
STAT6d

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 ...

Sarepta Therapeutics Stock Soars After FDA Removes Hold On Elevidys For Some Patients

Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

Sarepta Therapeutics shares traded lower in premarket trade on Tuesday, as the drugmaker relented to a Food and Drug ...

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...