Regeneron, Linvoseltamab and EU

Regeneron's linvoseltamab gets positive EU regulatory opinion
Regeneron Pharmaceuticals (NASDAQ:REGN) said the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of its drug linvoseltamab for the treatment of adults with relapsed and refractory multiple myeloma.
Regeneron Gets CHMP Backing of Linvoseltamab in Multiple Myeloma
Regeneron on Friday said the recommendation covers adults with adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have shown disease progression on the last therapy.
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
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 License Application for linvoseltamab. The target action date for the FDA decision is July 10, 2025.
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 issues. According to Regeneron, these issues have since been resolved.
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 target action date of July 10 for a decision.
Regeneron announces EMA CHMP adopted positive opinion on linvoseltamab
Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has
Regeneron Pharmaceuticals, Inc.: Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human
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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 expected by July 10, 2025.
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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 ...