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BioWorld - Wednesday, May 27, 2026
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Home » Regeneron wins FDA nod for BCMA bispecific Lynozyfic
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Regeneron wins FDA nod for BCMA bispecific Lynozyfic

July 2, 2025
By Jennifer Boggs
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It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.

BioWorld Regulatory Cancer Hematologic Bispecific antibody U.S. FDA

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