News

MIT Technology Review2d

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
Fierce Pharma2d

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 ...
BioSpace1d

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
STAT1d

Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...

InnovationRx: Sarepta Blinks In Showdown With FDA

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the 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 ...
Devdiscourse4d

Roche Pauses Shipments of Muscular Disorder Gene Therapy Elevidys Amid Safety Concerns

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...