Linvoseltamab BLA Accepted for FDA Review for the Treatment of …
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) …
Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple …
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 …
Regeneron Provides Update on Biologics License Application for ...
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 …
Regeneron announces EMA CHMP adopted positive opinion on linvoseltamab …
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 …
Regeneron Gets CHMP Backing of Linvoseltamab in Multiple …
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 Treatment of Relapsed/Refractory Multiple …
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 …
Linvoseltamab Recommended for EU Approval by the CHMP to
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 …
FDA accepts Regeneron’s BLA for linvoseltamab for review
Feb 22, 2024 · The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ biologics licence application (BLA) for linvoseltamab to treat multiple …
Linvoseltamab BLA Accepted for FDA Review for the Treatment of …
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 …
Linvoseltamab Recommended for EU Approval by the CHMP to …
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 …
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