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 ...

Drug cost-effectiveness organisation ICER has revised its view of Eisai’s new Alzheimer’s disease therapy Leqembi, but has concluded that the price set by the pharma group is still too high.

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 ...

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...

Susvimo is also approved to treat age-related macular degeneration, and the medication, ranibizumab, is delivered though a refillable ocular implant. The FDA has approved Genentech’s Susvimo ...

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