Just 16 months after Johnson & Johnson scored its initial FDA app | Sixteen months after Johnson & Johnson scored its initial FDA approval for Imaavy, the pharma giant has tacked on a label expansion for the monoclonal antibody. The U.S. regulator has signed off on Imaavy to treat warm autoimmune hemolytic anemia, a rare disorder which destroys red blood cells.

FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients

Johnson & Johnson secured FDA approval for IMAAVY, the first targeted therapy to treat warm autoimmune hemolytic anemia in adults and youth.