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

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 ...

MRK posts encouraging Q4 results. However, the decision to temporarily halt shipments of Gardasil vaccines to China has ...

Delayed REM sleep may be linked to a higher risk of Alzheimer’s disease, new research found. Here's how to build a healthy sleep routine.

Eisai and Biogen have completed their rolling ... with mild cognitive impairment or mild dementia in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, and GB so far, although recent ...

Welcome to the Merck & Company Q4 sales and earnings conference call. [Operator instructions] This call is being recorded. [Operator instructions] I would now like to turn the call over to Mr. Peter ...

Merck's combination of a wide lineup of high-margin drugs and a pipeline of new drugs should ensure strong returns on invested capital over the long term. Further, following the divestment of the ...

POET Technologies Inc. ("POET" or the "Company") , a leader in the design and implementation of highly-integrated optical engines and light sources for Artificial Intelligence networks, announces that ...