GlobalData on MSN2d
Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...
Alvotech, Teva announce FDA accepts BLA for AVT05
Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the U.S. FDA has ...
Hosted on MSN7d
REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA
Replimune Group, Inc. REPL announced that the FDA has accepted the biologics license application (BLA) for its lead pipeline ...
Targeted Oncology8d
FDA Accepts BLA for RP1 With Nivolumab in Advanced Melanoma
The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
Targeted Oncology13d
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 ...
Healio14d
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 individuals with mild cognitive impairment or mild dementia consistent with early ...
JCN Newswire14d
FDA Accepts LEQEMBI (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease
TOKYO and CAMBRIDGE, Mass., Jan 15, 2025 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License ...
Yahoo Finance16d
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 ...
Sharecast16d
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 ...