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FDA, Sarepta and gene therapy

FDA opens probe into mysterious death linked to gene therapy

The U.S. Food & Drug Administration announced Friday that it has launched an investigation into the death of an 8‑year‑old boy who received Elevidys, the gene therapy developed by Sarepta Therapeutic...

· 19h · on MSN

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

· 19h · on MSN

FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys

· 3h

What’s behind Sarepta’s gene therapy deaths?

Three patient deaths linked to neuromuscular drugs developed by Sarepta Therapeutics ( NASDAQ: SRPT) have drawn regulatory scrutiny on the viral vector used in the company’s gene therapy platform tech...

STAT · 1d

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

· 1d

EU panel declines backing Sarepta-Roche gene therapy for Duchenne

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 anonymous senior FDA official. Given Elevidys’ full approval, however, experts told BioSpace this path would set up a length legal battle between the regulator and

4don MSN

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

Sarepta Therapeutics shares were lower in premarket trading on Tuesday, as the drugmaker relented to a Food and Drug Administration request to halt shipments of a gene therapy.

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, ARCH Venture's latest biotech company, and more.

Investor's Business Daily on MSN1d

The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent' For Gene Therapies.

Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical testing to validate the safety profile of its controversial gene therapy, Elevidys.

STAT3d

Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more

Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the market

4don MSN

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

Sarepta stock fell after it agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular dystrophy following a request from the FDA.

5don MSN

Sarepta extends losses premarket after refusing FDA’s halt request

Sarepta Therapeutics (NASDAQ:SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second session after plunging 36% on Friday. The decline follows the company's refusal to halt all shipments of its Elevidys gene therapy,

STAT5dOpinion

The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear

The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with data, is the surest path forward.