The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...

The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...

Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...

TOKYO -- Japanese drugmaker Eisai will make its Alzheimer's disease treatment Leqembi available for at-home administration by fiscal 2025 in the U.S., where thousands of patients are waiting to ...

Merck & Co. and Eisai have to deal with the reality that yet another phase 3 trial of their combination of Keytruda and ...

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...

The U.S. Food and Drug Administration in 2023 approved Leqembi, which is also approved in the U.K., Japan, China and several other countries. Japan's Eisai serves as the lead for Leqembi's ...

The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.

In recent health developments, Akero Therapeutics' drug shows promise for liver disease, Eisai/Biogen's Alzheimer's drug ...