Yahoo Finance20d
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 Today17d
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 Insider20d
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 ...
Nasdaq20d
Regeneron Pharma Says FDA Accepted BLA For Linvoseltamab To Treat Multiple Myeloma
(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) Tuesday said that the resubmission of Biologics License Application (BLA) for linvoseltamab for the treatment of multiple myeloma has been ...
MarketWatch20d
Regeneron Gets New FDA Review of Linvoseltamab for Multiple Myeloma
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.
Nasdaq20d
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 ...