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 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 ...
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 ...
Sarepta can begin shipping Elevidys therapy after FDA reverses pause, stock soars
Sarepta will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the US Food and Drug Administration ...
Fierce Pharma5d
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 recommends lifting voluntary hold on Elevidys in ambulatory patients
FDA recommends lifting the hold on Sarepta's gene therapy Elevidys for ambulatory patients after investigation; ...
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 ...
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) ...
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
FDA Probes Death of Patient on Sarepta's Elevidys, Partner Roche Says Death Unrelated to Therapy
(Reuters) -The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who ...
BioSpace8d
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...