This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2021
  • /
  • 5
  • /
  • Omeros announces extension for FDA review of narso...

Omeros announces extension for FDA review of narsolimab to treat HSCT-TMA.

Read time: 1 mins
Published:24th May 2021
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

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.