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 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 ...

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 ...

(RTTNews) - Regeneron Pharmaceuticals (REGN) announced the CHMP has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed 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 ...

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 (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 ...

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 ...