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 ...
BioSpace4d
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 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 ...
Southwest Journal14d
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% ...
Sarepta denies Elevidys is linked to latest patient death in Brazil
Shortly after the U.S. FDA announced an investigation into the death of a patient who had received Elevidys, a gene therapy ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, putting additional pressure on the biotech company after the recent deaths ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
BioSpace14d
Sarepta Reports a Third Gene-Therapy Related Patient Death
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute ...
Fierce Pharma7d
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
The Pharma Letter4d
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 ...
Sarepta plunges after third patient death tied to gene therapy - report
Sarepta Therapeutics (SRPT) said a third patient has died from acute liver failure after receiving one of its gene therapies, intensifying scrutiny over the safety of its treatments, Bloomberg ...
Becker's Hospital Review13d
Sarepta reports 3rd patient death after gene therapy treatment
A third patient has died from acute liver failure after receiving a gene therapy treatment from Sarepta Therapeutics, the biotech company confirmed to Bloomberg on July 18. The patient died while ...