Monthly Prescribing Reference19d
Linvoseltamab Under Review for Relapsed/Refractory Multiple Myeloma
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 ...
Yahoo Finance19d
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
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 ...
Cure Today16d
Linvoseltamab BLA Resubmission Accepted by FDA for Review
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 ...
Business Insider19d
Regeneron announces FDA acceptance of BLA for linvoseltamab
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 ...
Nasdaq19d
Regeneron Pharmaceuticals' Linvoseltamab BLA Resubmission Accepted by FDA for Review in Relapsed/Refractory 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 ...
WGN Radio19d
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
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 ...