News

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 ...
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 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 ...
Fierce Pharma2d
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 Boy in Brazil on Sarepta’s Elevidys
US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
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 ...
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 ...
BioSpace3d
Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
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) ...
Southwest Journal13d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
News Nation on MSN3d
Parents urge FDA to restore gene therapy after distribution pause
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
TipRanks on MSN2d
FDA tells Sarepta it may may lift its voluntary pause on shipments of Elevidys
Therapeutics announced that the U.S. FDA notified Sarepta that it may lift its voluntary pause on shipments of ELEVIDYS for ...