Feb 11, 2025 · 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. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the ...

TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has ...

Aug 20, 2024 · Regeneron is committed to working closely with the third-party fill/finish manufacturer and the FDA to bring linvoseltamab to appropriate patients with R/R MM as quickly as possible, which is critical because most MM patients relapse and ultimately require additional therapies in late-line settings.

1 day ago · Regeneron (REGN) Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has adopted a positive opinion recommending ...

1 day ago · Regeneron Pharmaceuticals said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended conditional marketing approval of linvoseltamab for certain adults ...

Jun 16, 2024 · We present a phase I/II first-in-human trial evaluating the safety and efficacy of 50 mg and 200 mg doses of linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody in relapsed/refractory multiple myeloma (RRMM).

1 day ago · Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma February 28, 2025 07:00 ET | Source: Regeneron Pharmaceuticals, Inc.

Feb 22, 2024 · The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ biologics licence application (BLA) for linvoseltamab to treat multiple …

TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple ...

1 day ago · --Regeneron Pharmaceuticals, Inc. today announced that the European Medicines Agency’ s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional ...