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.

The BLA is supported by data from the pivotal LINKER-MM1 trial investigating linvoseltamab in R/R MM, and linvoseltamab is also under review by the European Medicines Agency (EMA) for the same ...

Linvoseltamab's BLA resubmission is under FDA review, with a decision anticipated by July 2025, supported by LINKER-MM1 trial data. The trial evaluates linvoseltamab's safety, tolerability, and ...

Regeneron Pharmaceuticals has reported encouraging results from the Phase I/II LINKER-MM1 clinical trial of its investigational bispecific antibody, linvoseltamab, in patients with relapsed ...

Regeneron (REGN) announced that the U.S. Food and Drug Administration has accepted for review the resubmission of the Biologics License Application for linvoseltamab for the treatment of adult ...

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) Tuesday said that the resubmission of Biologics License Application (BLA) for linvoseltamab for the treatment of multiple myeloma has been ...

Regeneron Pharmaceuticals said the Food and Drug Administration has accepted its resubmitted application seeking approval of linvoseltamab for certain patients with the blood cancer multiple myeloma.

Regeneron Pharmaceuticals announced that the FDA has accepted the resubmission of its Biologics License Application (BLA) for linvoseltamab, an investigational treatment for adult patients with ...