Regeneron Pharmaceuticals, Inc.: Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
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.
manilatimes3h
Yaqrit prepares phase 3 for ammonia scavenger in hepatic encephalopathy
Yaqrit acquired full global rights, including development and commercial, for OPA in any indication from Mallinckrodt Pharmaceuticals in the second half of 2024. Mallinckrodt Pharmaceuticals will ...
Daily4h
EMA establishes regular procedure for scientific advice on certain high-risk medical devices
European Medicines Agency (EMA), in close collaboration with the European Commission, has established a standard procedure ...
cidrap.umn16h
FDA approves combination antibiotic for difficult-to-treat infections
Emblaveo (aztreonam-avibactam) was approved for treating complicated intra-abdominal infections with limited or no treatment ...