GlobalData on MSN
FDA to review Eisai’s Leqembi Iqlik sBLA for Alzheimer’s
The FDA has set a Prescription Drug User Fee Act action date for 24 May 2026.
Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the ...
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced ...
CNW/ - Eisai Limited, a leading research and development-based pharmaceutical company specializing in neurology and oncology, ...
Eisai has reached a license agreement with Nuvation Bio, a global oncology company focused on tackling some of the toughest challenges in cancer treatment, that significantly expands the long-term ...
Eisai and Biogen’s Supplemental Biologics License Application (sBLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) has been accepted by the US FDA under Priority Review to treat early ...
Concerns are mounting about the safety of Eisai and Biogen’s Alzheimer’s disease prospect lecanemab. Ahead of the presentation of the full phase 3 dataset on Tuesday, Science has reported on the death ...
Nuvation Bio (NUVB) just signed an exclusive license and collaboration deal with Japan based Eisai that hands Eisai ...
Mission Based Media has launched “Rethinking Alzheimer’s Disease,” a podcast miniseries focused on the incurable condition. It’s backed by Japanese biotech Eisai, which jointly developed Alzheimer’s ...
LEQEMBI is currently approved in 53 countries and regions and is under regulatory review in 7 countries. In August 2025, the US FDA approved LEQEMBI IQLIK 360 mg for weekly subcutaneous maintenance ...
If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results