The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...

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

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

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

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

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

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...

We now have two FDA-approved disease-modifying treatments for Alzheimer's disease, and hundreds of clinical trials are ...

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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 ...