Cure Today22h
Linvoseltamab BLA Resubmission Accepted by FDA for Review
The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision ...
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
Managed Healthcare Executive3d
FDA Sets Review Date for Linvoseltamab for Multiple Myeloma
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...
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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 ...
Monthly Prescribing Reference3d
Linvoseltamab Under Review for Relapsed/Refractory Multiple Myeloma
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 ...
Regeneron Pharmaceuticals, Inc.: Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.
Regeneron Gets New FDA Review of Linvoseltamab for Multiple Myeloma
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 ...
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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 ...