The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site.

Regeneron’s bid to join the market for BCMA-targeted bispecific antibodies for multiple myeloma is nearing a conclusion, with the FDA starting a priority review of its linvoseltamab drug candidate.

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ Biologics Licence Application (BLA) for linvoseltamab to treat multiple myeloma (MM), for priority review.

Regeneron has moved closer to a regulatory filing for its BCMAxCD3 bispecific antibody linvoseltamab, the first of a series of bispecifics that is spearheading its oncology pipeline. New data from ...

Linvoseltamab (BCMAxCD3) for multiple myeloma: Linvoseltamab has potential to be the best-in-class BCMAxCD3 bispecific with its differentiated clinical profile, dosing regimen and administration ...