Regeneron Gets CHMP Backing of Linvoseltamab

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.
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
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.
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.
The Pharma Letter8h
Three novel medicines recommended for approval by EMA/CHMP
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its ...
Cure Today15d
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.
pharmaphorum4d
Regeneron bids to join the BCMA bispecific camp
Regeneron has moved closer to a regulatory filing for its BCMAxCD3 bispecific antibody linvoseltamab, the first of a series of bispecifics that is spearheading its oncology pipeline. New data from ...
Why Regeneron's Price May Soon Break Out
Regeneron Pharmaceuticals' fourth quarter results beat my and Wall Street analysts' expectations. See why REGN stock is a top ...
Investing3d
Regeneron's SWOT analysis: biotech stock faces eylea challenges, pipeline promise
Regeneron Pharmaceuticals (NASDAQ ... including fianlimab (anti-LAG-3 antibody) and linvoseltamab, has caught investor attention. Fianlimab, in particular, has shown promise in melanoma treatment ...