Human acellular vessel biologics license application granted priority review by US FDA for the treatment of vascular trauma


9 February 2024 - PDUFA date set for 10 August 2024.

Humacyte today announced that the US FDA has accepted and granted priority review to Humacyte’s biologics license application seeking approval of the human acellular vessel in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.

Read Humacyte press release

Michael Wonder

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Michael Wonder

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US , Dossier , Cellular therapy