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Sarepta to continue Elevidys 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,

Bloomberg on MSN · 2d

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.

MarketWatch · 8h

FDA Places Sarepta's Investigational Gene-Therapy Trials on Hold Following Patient Death

Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was linked to the deaths of two teenage boys earlier this year.

18hon 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 ...

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 ...

7hon MSN

Stocks set more records as Verizon begins a big week for profit reports with a beat

Verizon Communications helped lead the way and rose 4%. The telecom giant reported a stronger profit for the latest quarter than analysts expected, along with higher revenue than forecast. Following ...

Sarepta Stock Continues to Fall After Patient Death Linked to Investigational Gene Therapy

Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...

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.

4don MSN

Sarepta to cut 500 jobs, add black-box warning on gene therapy

Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients ...

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