News

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 ...
BioSpace12h
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 ...
BioSpace3h
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 ...
Fierce Pharma11h
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 to Lift Pause on Shipments of Duchenne Treatment Elevidys
Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...
The Pharma Letter14h
Patient death in Brazil not related to Elevidys, Sarepta says
The US Food and Drug Administration (FDA) issued a press release late Friday announcing an investigation into the death of an ...
Fierce Pharma4h
FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...
TipRanks on MSN5h
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 ...
Stocktwits on MSN21h
Retail Bulls Stick With Sarepta After 8-Year-Old Patient’s Death Deemed Unrelated To DMD Gene Therapy
Retail sentiment around Sarepta Therapeutics remained upbeat on Monday after the company said Friday that the death of an ...
Rheumatology Advisor12h
Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products
The Food and Drug Administration is investigating Sarepta’s gene therapy products following reports of a third death from acute liver failure.
MedPage Today on MSN12h
RFK Jr. and Jeffrey Epstein; Death Linked to Surgical Stapler; Rabies Cases Rising
Note that some links may require registration or subscription. HHS Secretary Robert F. Kennedy Jr. is facing new questions ...
Los Angeles Business Journal19h
Arrowhead Shares Bumpy After Partner Troubles
When Pasadena-based Arrowhead Pharmaceuticals Inc. signed a huge licensing and collaboration deal with Cambridge, ...