News

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 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 ...

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 ...
BioSpace4d

‘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 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 ...

Sarepta, other Mass. biotech stocks rise on Prasad’s FDA exit

Massachusetts biotechs saw their stock prices rise after news broke that FDA Vinay Prasad is leaving the agency.
Fierce Pharma10d

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 ...
The American Journal of Managed Care7d

FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
BioSpace10d

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 ...

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 ...

Sarepta can begin shipping Elevidys therapy after FDA reverses pause, stock soars

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...
Fierce Pharma8d

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 ...