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 ...
Levi & Korsinsky Reminds Atara Biotherapeutics, Inc. Investors of the Ongoing Investigation into Potential Violations of Securities Laws – ATRA
NEW YORK CITY, NY / ACCESS Newswire / January 20, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Atara ...
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 ...
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 ...
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 ...
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 ...
ophthalmologytimes4d
Outlook Therapeutics completes analysis of 12-week safety and efficacy results of NORSE EIGHT
The trial evaluated ONS-5010 in wet age-related macular degeneration patients, and the company plans to resubmit a Biologics ...
Morningstar7d
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 ...
Finanznachrichten7d
BioArctic: FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi (lecanemab-irmb) in the US
STOCKHOLM, Jan. 14, 2025 /PRNewswire/ --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 ...