FDA Halts Elevidys Shipments

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FDA, Sarepta and Elevidys

Sarepta Soars After FDA Says Some Patients Can Get Elevidys

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.

· 17h

FDA allows Sarepta to resume some Elevidys shipments

Fierce Pharma · 17h

FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients

pharmaphorum4h

FDA gives the go-ahead to restart Elevidys shipments

In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

Fierce Pharma6d

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 ...

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FDA, Sarepta and Elevidys

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