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News about "Eisai "
LEQEMBI IQLIK Subcutaneous Dose Gets US FDA Priority Review for Early Alzheimer's Disease
LEQEMBI IQLIK subcutaneous dose review by US Food and Drug Administration (FDA) extended after major sBLA amendment for early Alzheimer’s disease, with no approvability concerns raised.
Eisai | 11/05/2026 | By News Bureau
Eisai and Nuvation Bio Secure EMA Validation for Taletrectinib in Lung Cancer
EU regulator begins review of next-generation targeted therapy for advanced ROS1-positive non-small cell lung cancer.
Eisai | 30/03/2026 | By News Bureau | 138
Eisai Submits EMA Application for Once-Monthly Maintenance Dosing of Alzheimer's Drug Lecanemab
BioArctic partner Eisai has filed a Marketing Authorisation Variation with the EMA seeking approval for a once-every-four-weeks IV maintenance dosing regimen for lecanemab in early Alzheimer’s disease.
Eisai | 27/01/2026 | By News Bureau | 109
Eisai, Nuvation Bio Collaborates to Expand Taletrectinib's Global Reach
The collaboration between Eisai and Nuvation to expand global development and commercialisation of taletrectinib for ROS1-positive non-small cell lung cancer.
Eisai | 15/01/2026 | By News Bureau | 239
China Adds Leqembi to Innovative Drug Insurance List
BioArctic’s partner Eisai said Leqembi has been added to China’s new Commercial Insurance Innovative Drug List, a move by the NHSA that broadens access to the Alzheimer’s therapy for patients in the early stages of the disease.
Eisai | 09/12/2025 | By Akanki | 277
Eisai completes FDA submission for weekly subcutaneous LEQEMBI autoinjector
Eisai has completed the rolling submission of its Supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for LEQEMBI IQLIK, a once-weekly subcutaneous autoinjector formulation of lecanemab-irmb (LEQEMBI), following the FDA’s Fast Track designation.
Eisai | 27/11/2025 | By Darshana | 169
Health Canada Grants Authorisation for Leqembi (Lecanemab)
BioArctic has the right to commercialise Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialisation in the region.
Eisai | 28/10/2025 | By Dineshwori | 233
Eisai Signs Deal to Develop Tasurgratinib in Greater China Region with SciClone
Eisai will maintain the rights to tasurgratinib worldwide outside of the licensed regions and continue to manufacture and market it in Japan, where it has been already launched.
Eisai | 01/03/2025 | By Aishwarya | 380
Leqembi sBLA for Alzheimers IV Maintenance Moves Forward with FDA
Eisai has submitted a supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb intravenous (IV) maintenance dosing to the US Food and Drug Administration (FDA).
Eisai | 01/04/2024 | By Manvi | 662
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