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Axogen Submits Biologics License Application to US FDA for Avance Nerve Graft
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Axogen Submits Biologics License Application to US FDA for Avance Nerve Graft
Sep 6, 2024 1:28 PM

07:46 AM EDT, 09/06/2024 (MT Newswires) -- Axogen ( AXGN ) said Friday that it has completed the rolling submission process for a biologics license application for Avance Nerve Graft to the US Food and Drug Administration.

The company said it expects to be notified within the next 60 days on whether the application has been accepted for review.

Axogen ( AXGN ) said it has requested a priority review status for the application, which would reduce the review timeline to six months from the standard 10 months if granted.

Avance Nerve Graft is a processed human nerve allograft intended to repair severed peripheral nerves, the company said.

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