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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 ...
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 ...

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 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 ...

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% ...
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 ...

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; ...