Regeneron Pharmaceuticals has received accelerated approval from the U.S. Food and Drug Administration (FDA) for Lynozyfic (linvoseltamab), a treatment for relapsed or refractory multiple myeloma in patients who have undergone four or more prior therapies. This approval, granted ahead of the Prescription Drug User Fee Act (PDUFA) date by eight days, is based on response data from the LINKER-MM1 clinical trial (NCT03761108). Lynozyfic is notable for being the first FDA-approved bispecific antibody targeting BCMAxCD3. The drug is seen as Regeneron's effort to catch up with competitors Johnson & Johnson and Pfizer in the multiple myeloma treatment market, with some reports highlighting a dosing advantage over existing therapies. The approval marks a significant development in oncology therapeutics for blood cancer patients with limited treatment options.