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

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

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

Eisai has filed to extend the label for its Alzheimer’s disease therapy Leqembi to include a maintenance ... that is specific to the subcutaneous form. In a statement, Eisai and Biogen said ...

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

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the ...

but is developing both IV and subcutaneous forms of its follow-up amyloid drug remternetug, which is in phase 3 testing. The FDA has awarded fast-track status for subcutaneous Leqembi but so far ...

With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.