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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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,

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Sarepta's Setback Deepens With Another Gene Therapy Fatality

Southwest Journal · 1d

Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy

· 19h

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

The U.S. Food and Drug Administration will request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Fri...

· 19h

Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript

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Sarepta shares slump after third patient death this year

STAT20h

Patient dies in Sarepta gene therapy trial, adding to safety concerns

A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to the company's gene therapies

13hon 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 effort to cut annual operating costs by hundreds of millions of dollars.

Managed Healthcare Executive18h

Gene Therapy for Inherited Macular Degeneration Begins Pivotal Trial

In early research, OCU410ST, a gene therapy for Stargardt disease, demonstrated slowed lesion growth by 48% at the 12-month follow-up in evaluable treated eyes.

10don 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.

Pharmabiz1d

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 Healthcare3d

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 Therapy Access Model. | As expected, there will be 35 voluntary participants in the CMS' new Cell and Gene Therapy Access Model.

InvestorsHub on MSN1d

Rocket Pharmaceuticals Shares Jump After FDA Grants Accelerated Review Status to Gene Therapy

Rocket Pharmaceuticals Inc. (NASDAQ:RCKT) surged 15% after receiving a key regulatory boost from the U.S. Food and Drug Administration (FDA), which granted its investigational gene therapy RP-A601 the Regenerative Medicine Advanced Therapy (RMAT) designation.

BioSpace2d

Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.