News
Omeros announces extension for FDA review of narsolimab to treat HSCT-TMA.
Omeros Corporation reported that the FDA will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The new Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021. As part of the ongoing BLA Priority Review, Omeros recently submitted a response to an FDA information request. FDA has classified the response as a major amendment, which requires additional time to review.
Condition: Thrombotic Microangiopathies /HSCT- TMA
Type: drug
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