Healio5d
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 ...
Targeted Oncology4d
FDA Issues Complete Response Letter for Tab-cel in EBV+ PTLD
The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for ...
Morningstar6d
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 ...
Medscape3d
FDA Approves New ADC for HR+, HER2- Breast Cancer
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...
Tanvex BioPharma Completes Acquisition of Bora Biologics, Launching New Era in Biologics Development
As Bora Biologics, the organization will continue to build upon its established reputation for quality and excellence in ...
Monthly Prescribing Reference3d
Lecanemab SC Formulation Under Review for Early Alzheimer Disease
The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for subcutaneous (SC) maintenance dosing of lecanemab-irmb for the treatment of Alzheimer disease (AD) in ...
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 ...