The Washington University trial comes as part of a larger platform study which hopes to understand if Alzheimer's disease can ...

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

New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver ...

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...

We recently compiled a list of the 12 Best S&P 500 Stocks to Invest in According to Analysts. In this article, we are going ...

An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...

European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for ...

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 ...

The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...