sarepta duchenne muscular dystrophy

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Sarepta's Duchenne Therapy Sparked Fears

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.

STAT · 1d

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

Bloomberg on MSN · 1d

Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

FDA, Sarepta

Bloomberg on MSN · 6h

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 the market until the company can persuade US regulators that it won’t cause more deaths,

Forbes · 11h

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. To get it in your inbox, subscribe here.

Barron's on MSN · 1d

Sarepta Stock Falls. Why It’s Caving In to the FDA and What Comes Next.

The company agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular dystrophy.

Sarepta stock faces multiple downgrades and questions of solvency amid Elevidys pause

For Sarepta, the hits keep coming, with several downgrades in the past week after it was forced to temporarily take its top-selling drug off the market.

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

3don 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 ...

BioSpace15h

Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries

Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...

1don MSN

Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

Sarepta Therapeutics (NASDAQ:SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, ...

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