Eisai Seeks Traditional Approval With New Lecanemab Data Und

Eisai Seeks Traditional Approval With New Lecanemab Data Under FDA Review

The FDA has accepted for Priority Review the sBLA for Leqembi (lecanemab-irmb) to convert its accelerated approval status to a traditional approval.

Related Keywords

, Drug Administration , Priority Review , Biologics License Application , Clinical Dementia Rating Sum , Scale Cognitive Subscale , Prescription Drug User Fee Act ,

© 2025 Vimarsana