FDA Approves LEQEMBI® (Lecanemab-Irmb) IV Maintenance Dosing for Early Alzheimer’s Disease Treatment Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb), allowing intravenous (IV) maintenance dosing every four weeks for patients with early-stage Alzheimer’s disease. LEQEMBI is intended for those in the mild … Continue reading FDA Approves LEQEMBI IV Dosing for Early Alzheimer’s; Vanda Accepts FDA Hearing on Tradipitant for Gastroparesis; Cartesian Gains FDA Protocol Approval for Myasthenia Gravis Trial; Zai Lab Secures FDA Orphan Status for DLL3 ADC in SCLC; Dyne Receives FDA Fast Track for DYNE-101 in Myotonic Dystrophy