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

The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...

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

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's ...

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 ...

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

Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE ...