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FDA asks Sarepta to stop shipping gene therapy

Reuters on MSN · 2d

Exclusive-US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.

Associated Press News on MSN · 2d

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 therapy.

MarketWatch · 2h

FDA Places Sarepta's Investigational Gene-Therapy Trials on Hold Following Patient Death

Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was linked to the deaths of two teenage boys earlier this year.

3h

Ocugen doses first subject in trial of modifier gene therapy candidate

Ocugen has dosed the first subject in its Phase II/III GARDian3 trial of modifier gene therapy candidate, OCU410ST ...

5hon MSN

Penn CRISPR science is the foundation for a gene-editing heart disease treatment under Eli Lilly

Penn's Kiran Musunuru spoke with The Inquirer about the future of CRISPR technology.

12don MSN

Researchers used gene therapy to restore hearing in adults

Groundbreaking new research shows that it is possible to use gene therapy to restore hearing in both children and adults.

2d

Sarepta's Setback Deepens With Another Gene Therapy Fatality

Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene ...

2d

Chinese scientists develop low-cost cell therapy for cancer, asthma and other illnesses

A team of Chinese medical experts say they can produce anti-cancer cells directly inside the human body using gene therapy ...

2don MSN

Gene-therapy company to eliminate 21 Durham employees as part of major restructuring

Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an ...

Miltenyi Biotec and THSTI FIVE partner to launch India’s first hands-on CAR-T cell and gene therapy training curriculum

Our Bureau, Mumbai Friday, July 18, 2025, 17:45 Hrs [IST] ...

Fierce Healthcare5d

CMS officially names participants in Cell and Gene Therapy Access Model

The Centers for Medicare and Medicaid Services (CMS) has selected 35 participants for its new, voluntary Cell and Gene ...

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