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

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

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 ...

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatmentAlzheimer's disease progression does ...

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody ...

The recent approvals of Leqembi (lecanemab) and Kisunla (donanemab) have refreshed the landscape of Alzheimer’s disease ...

The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...

A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two ...

The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...

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 ...