The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...
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 ...
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 ...
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 ...
The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for ...
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 ...
Acceptance of the Biologics License Application for subcutaneous Leqembi is based on results from the Clarity AD open-label extension and modeling of observed data in patients with Alzheimer disease.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback