However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025. Since its approval in 2023, the launch of the ...

It seems Eisai and Biogen have another hurdle to jump over in their bid to get EU approval for their Alzheimer's disease therapy Leqembi. In the latest development, the European Commission has ...

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the monthly intravenous (IV) maintenance regimen of Leqembi ® (lecanemab-irmb ...

EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to ...

The FDA has accepted Eisai and Biogen’s biologics license application for a subcutaneous autoinjector weekly maintenance dose of Leqembi for patients with mild cognitive impairment or mild ...

The European Medicines Agency (EMA) announced it will review new safety data on the Alzheimer’s disease drug Leqembi (lecanemab). This follows a prior decision to recommend its use in the ...

FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application. Leqembi's subcutaneous dosing allows Alzheimer's patients to administer weekly ...

Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration ...