FDA Halts Elevidys Shipments

News

FDA, Sarepta and gene therapy

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 muscular dystrophy patient who received a different, experimental treatment died,

cleveland.com · 20h

FDA opens probe into mysterious death linked to gene therapy

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne muscular dystrophy. U.S. distribution has been paused amid safety concerns.

Yahoo Finance · 5d

Sarepta under pressure: FDA requests halt of Elevidys shipments

Sarepta Therapeutics (SRPT) stock is in focus after the US Food and Drug Administration (FDA) asked the company to halt shipments of Elevidys, a treatment that has been linked to multiple patient deaths.

8don MSN

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, ...

GEN13h

FDA Probes Death of Brazilian Boy Linked to Sarepta’s Elevidys

Most important, Sarepta backed away from a confrontation with the FDA over Elevidys. The company on July 18 initially refused the agency’s request to voluntarily halt shipments of Elevidys ...

Devdiscourse5d

Sarepta Therapeutics Temporarily Halts Elevidys Shipments in Compliance with FDA Requests

Sarepta Therapeutics Inc has voluntarily paused shipments of Elevidys in the United States. The decision responds to FDA ...

Fierce Pharma3d

Roche halts Elevidys distribution in some countries, following Sarepta's lead in US

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

STAT4d

Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.

Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...

Results that may be inaccessible to you are currently showing.

Hide inaccessible results