News

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 ...

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.

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, ...
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 ...
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 ...

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

What’s behind Sarepta’s gene therapy deaths?

Three patient deaths linked to gene therapies developed by Sarepta Therapeutics (SRPT) have drawn FDA scrutiny on the viral ...

Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...

Sarepta denies Elevidys is linked to latest patient death in Brazil

Sarepta Therapeutics (SRPT) in focus as the biotech says the death of a patient who had received its gene therapy Elevidys ...
Devdiscourse4h

Health Sector Headlines: Shifts in Profits, Drug Developments, and Data-Sharing Innovations

HCA Healthcare raises 2025 profit forecast amidst insurance uncertainty while Centene anticipates a 2026 profitability boost ...
Fierce Pharma5d

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...