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News

Sarepta, FDA

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 · 8d · on MSN
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
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.

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Clinical Trials Arena on MSN · 4d
Sarepta halts Elevidys shipments following FDA pressure
 · 5d
Sarepta under pressure: FDA requests halt of Elevidys shipments
BioPharma Dive
4d

Sarepta stops Elevidys shipments after standoff with FDA

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...
6h

FDA opens probe into mysterious death linked to gene therapy

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...
pharmaphorum
4d

Sarepta backs down and pauses Elevidys shipments

The FDA appears to have won its staring contest with Sarepta over shipments of Elevidys, after the company blinked and agreed ...

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