The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Regeneron's Lynozyfic (linvoseltamab) for the treatment of relapsed or refractory multiple myeloma in patients who have undergone four or more prior therapies. This marks the first FDA-approved BCMAxCD3 bispecific antibody, with approval based on response data from the LINKER-MM1 clinical trial (NCT03761108). Meanwhile, in Europe, GlaxoSmithKline's (GSK) Blenrep has received approval from the European Union for treating relapsed or refractory multiple myeloma. Sanofi's Sarclisa has also been approved in Europe for multiple myeloma. Additionally, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for several treatments: Eli Lilly's Donanemab, AstraZeneca's Trixeo Aerosphere, Novo Nordisk's Alhemo (concizumab) with a recommended label expansion for haemophilia A and B without inhibitors, and Tryngolza (olezarsen) for familial chylomicronemia syndrome (FCS). These regulatory developments reflect ongoing advancements in therapies for blood cancers and rare diseases across the U.S. and European markets.