Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human ...
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 ...
Destiny 2’s endgame PvP activity, Trials of Osiris, returned for its first fixture in Episode Heresy on February 14, and long-awaited changes make it the easiest source of endgame weapons.
The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision expected by July 10, 2025.
Our research and collaborations to develop potential treatments ... most patients will ultimately experience cancer progression and require additional therapies. About the Linvoseltamab Clinical ...
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 ...
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.
(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) Tuesday said that the resubmission of Biologics License Application (BLA) for linvoseltamab for the treatment of multiple myeloma has been ...
Regeneron Pharmaceuticals said the Food and Drug Administration has accepted its resubmitted application seeking approval of linvoseltamab for certain patients with the blood cancer multiple myeloma.
“Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation linvoseltamab; the likelihood, timing, and scope of possible ...