Posted by Michael Wonder on 28 Apr 2026
FDA grants priority review for Imavvy (nipocalimab-aahu) as the potential first approved treatment for people living with warm auto-immune haemolytic anaemia
27 April 2026 - Johnson & Johnson announced today that the US FDA has granted priority review to the supplemental biologics license application for Imavvy (nipocalimab-aahu), confirming the urgent need for treatment options in warm auto-immune haemolytic anaemia.
Imavvy is the first therapy to receive FDA priority review for this condition.
