Posted by Michael Wonder on 09 Feb 2024
Johnson & Johnson's nipocalimab granted US FDA breakthrough therapy designation for the treatment of individuals at high risk for severe haemolytic disease of the foetus and newborn
9 February 2024 - Breakthrough therapy designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for haemolytic disease of the foetus and newborn.
Johnson & Johnson today announced that the US FDA has granted breakthrough therapy designation for nipocalimab for the treatment of allo-immunized pregnant individuals at high risk of severe haemolytic disease of the foetus and newborn.
