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Sarepta, FDA and Elevidys

Fierce Pharma · 18h

FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to Bloomberg News that linked the probe to a fatality in Brazil and held that the death of the patient was unrelated to Elevidys itself.

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FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

· 9h · on MSN

Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

19hon MSN

Sarepta Stock Rises Despite Downgrade and FDA Probe. The Crisis Explained.

Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...

Fierce Pharma5d

Roche halts Elevidys distribution in some countries, following Sarepta's lead in US

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

BioPharma Dive3d

Sarepta woes mount as Duchenne gene therapy knocked back in Europe

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

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