Duchenne Families Sarepta Impact

News

FDA partially lifts hold on Sarepta's Duchenne gene therapy

FDA partially lifts hold on Sarepta's Duchenne gene therapy after community outcry

The FDA has partially reversed course on its push to halt shipments of a controversial gene therapy made by Sarepta Therapeutics.

STAT · 8h

FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to some patients.

Bloomberg on MSN · 10d

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, according to a person familiar with the matter.

Medical Marketing & Media13h

Five things for pharma marketers to know: Monday, July 28, 2025

Sarepta decision to halt Duchenne treatment continues to frustrate families; FDA reinstate a quarter of DOGE cuts; Contract research organizations report higher than expected pharma and biotech Q2 ...

PharmExec5d

Recapping the Sarepta Saga—And Implications for Industry

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...

8don MSN

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Pharmabiz20h

CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy

CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy: Basel Monday, July 28, 2025, 15:00 Hrs [I ...

Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS

Report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA ...

10d

Sarepta Therapeutics Stock Plunges Over 30% In Friday Pre-Market: What's Going On

Shares of Sarepta Therapeutics (NASDAQ: SRPT) plunged 26.85% in Friday pre-market after a clinical trial participant died ...

13h

Parents urge FDA to restore gene therapy after distribution pause

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

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