Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA

Omeros Corporation

20 May 2021 - PDUFA date is 17 October 2021.

Omeros Corporation today reported that the U.S. FDA will require additional time to review the biologics license application for narsoplimab for the treatment of haematopoietic stem cell transplant-associated thrombotic microangiopathy.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Timelines , Dossier