Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European ...

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, ...

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 ...

Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has ...

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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 ...

AbbVie got FDA approval for antibiotic treatment Emblaveo. Regeneron’s Linvoseltamab BLA was accepted for FDA review for the treatment of relapsed/refractory multiple myeloma. FDA has approved an ...

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TARRYTOWN, NY, USA I February 11, 2025 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the ...

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 ...