News about "Eisai "

US FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer's Disease

The US Food and Drug Administration (FDA) has approved Leqembi Iqlik (lecanemab-irmb) as a once-weekly subcutaneous starting dose for early Alzheimer's Disease (AD), with a U.S. launch planned for August 2026.

Eisai | 14/07/2026 | By News Bureau

Nuvation Bio's Taletrectinib Advances UK Regulatory Review for ROS1-Positive Lung Cancer

The UK's MHRA has validated the marketing application for Nuvation Bio's taletrectinib, bringing the next-generation ROS1 inhibitor one step closer to approval for patients with advanced ROS1-positive non-small cell lung cancer in the UK.

Eisai | 01/07/2026 | By News Bureau

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 |  122

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 |  185

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 |  120

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 |  269

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 |  306

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 |  184

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 |  246

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 |  411