The combination of subcutaneous daratumumab with VRd was approved in July 2024 for induction and consolidation in patients ...
Monash University researchers, alongside key partner Halozyme Therapeutics, report findings in support of shifting the way ...
The FDA has accepted for review the sBLA for subcutaneous lecanemab-irmb as a weekly starting dose for Alzheimer disease.
Subcutaneous administration takes less time and is tied to fewer administration-related reactions than intravenous.
With star checkpoint inhibitors like Keytruda and Opdivo now sporting subcutaneous formulations, GSK has struck a deal aimed ...
GlobalData on MSN
FDA to review Eisai’s Leqembi Iqlik sBLA for Alzheimer’s
The FDA has set a Prescription Drug User Fee Act action date for 24 May 2026.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced ...
BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting ...
The US regulator expects to issue a decision on Eisai's application for Leqembi Iqlik, which it has granted priority review, by May 24.
KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and ...
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 ...
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