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

The FDA last month accepted the application for subcutaneous Leqembi for maintenance dosing, with a target action date of ...

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

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

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule 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 European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to ...

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with ...

Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...