The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision ...

Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...

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 PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...

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

Regeneron, which is seeking FDA approval of linvoseltamab for adults with relapsed/refractory multiple myeloma that has progressed after at least three prior therapies, said the agency set a new ...

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.

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 ...

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 ...