GlobalData on MSN10d
Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...
Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
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 ...
pharmaphorum6d
EMA experts will look again at Leqembi's safety data
In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...
BioSpace10d
Biogen, Eisai Win Nod for Monthly Leqembi Maintenance Amid Stagnant Sales
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...
Europe to review safety data for Eisai-Biogen Alzheimer's drug
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...
FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's ...
Neurology Advisor1d
Leqembi Monthly IV Maintenance Dosing Approved for Early Alzheimer Disease
The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.
Yahoo Finance23d
Eisai and Biogen’s subcutaneous Leqembi set for FDA review
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 ...
MM&M10d
Biogen, Eisai receive FDA nod for monthly Leqembi IV maintenance dosing
The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.