The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.
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Biogen Stock Down on Regulatory Update in the EU for Alzheimer's DrugThe EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...
In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...
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 Washington University trial comes as part of a larger platform study which hopes to understand if Alzheimer's disease can ...
Novartis issued stronger guidance than Wall Street expected. Elsewhere, Eisai and Biogen’s Alzheimer’s drug will get a closer ...
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
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