The combination of subcutaneous daratumumab with VRd was approved in July 2024 for induction and consolidation in patients ...
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration ...
The FDA has accepted for review the sBLA for subcutaneous lecanemab-irmb as a weekly starting dose for Alzheimer disease.
Eisai and Biogen’s Supplemental Biologics License Application (sBLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) has been accepted by the US FDA under Priority Review to treat early ...
Dr. Balazs Halmos discusses the significance of the FDA approval of the subcutaneous injection formulation of Opdivo for patients with solid tumors. The Food and Drug Administration (FDA) approval of ...
LEQEMBI is currently approved in 53 countries and regions and is under regulatory review in 7 countries. In August 2025, the US FDA approved LEQEMBI IQLIK 360 mg for weekly subcutaneous maintenance ...
Please provide your email address to receive an email when new articles are posted on . Opdivo was previously only available intravenously. The approval comes after CHECKMATE-67T study results. Opdivo ...
Please provide your email address to receive an email when new articles are posted on . Genentech announced it received FDA approval for Ocrevus Zunovo to treat patients with relapsing and primary ...
– Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on Ocrevus levels in the blood over 12 weeks – – Ocrevus subcutaneous injection was ...
Roche Holdings AG's (OTC:RHHBY) Phase 3 OCARINA II trial evaluating Ocrevus (ocrelizumab) as a twice-a-year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with ...
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced ...