Healio14h
FDA grants biologics license application for monthly IV Leqembi
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...
FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi ...
Morningstar2d
FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of ...
EQS-News: Important milestone for Biotest: Biologics License Application for Fibrinogen submitted to the US Food and Drug Administration (FDA)
Important milestone for Biotest: Biologics License Application for Fibrinogen submitted to the US Food and Drug Administration (FDA) Biotest's fibrinogen aims to fulfill a high unmet medical need for ...
Finanznachrichten1d
BioArctic: FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi (lecanemab-irmb) in the US
A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was accepted by the U.S. Food and Drug Administration (FDA) in June 2024, with PDUFA date ...
PMLiVE19h
Biogen/Eisai announce FDA BLA acceptance for injectable Alzheimer’s drug
Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application ...
AstraZeneca, Daiichi Sankyo datopotamab deruxtecan BLA granted priority review
Daiichi Sankyo and AstraZeneca’s (AZN) biologics license application for datopotamab deruxtecan has been accepted and granted priority review ...