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Sarepta, Elevidys

Roche pauses shipments of Elevidys gene therapy outside US

Roche Holding AG (ROG.S) said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Ther...

· 2d · on MSN

Sarepta Changes Course, Agrees to Pause Elevidys Shipments

· 1d

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

· 13h

InnovationRx: Sarepta Blinks In Showdown With FDA

Last week, in a remarkable showdown, Sarepta Therapeutics refused to stop distribution of Elevidys, its therapy for the muscle-wasting disease Duchenne muscular dystrophy as the FDA had requested.

· 1d

Sarepta falls after gene therapy maker pauses Elevidys shipments in US

· 1d

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

STAT · 1d

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

But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries — which have been tied to the deaths of two patients — the official added.

· 1d

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

STAT · 1d

In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

8hon MSN

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,

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 gene therapy trials for limb girdle muscular dystrophy following three patient deaths potentially linked to the company's treatments.

1mon

Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures

The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.

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Sarepta

Gene therapy

Duchenne muscular dystrophy

Food and Drug Administration

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