Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has ...

Linvoseltamab is an investigational B-cell maturation antigen CD3-targeted bispecific antibody. The BLA resubmission was needed as the original application could not be approved due to manufacturing ...

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...

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 ...

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 ...

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 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 ...

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 patient ...