The FDA has accepted the resubmitted biologics license application (BLA) for linvoseltamab (REGN5458) for the treatment of heavily pretreated adults with relapsed/refractory multiple myeloma. The ...

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 ...

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 ...

A Prescription Drug User Fee Act target date of July 10, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted the resubmitted Biologics License ...

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 ...

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 ...