FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer’s Disease in the US January 26, 2025
FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S. January 17, 2025
FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US January 14, 2025
Lundbeck announces FDA plans to host an Advisory Committee meeting on the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD January 9, 2025
Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis December 14, 2024
U.S. FDA Approves AOP Health’s Rapiblyk™ (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting November 27, 2024
BLA for pegzilarginase in the treatment of arginase 1 deficiency (ARG1-D) accepted for priority review by the U.S. FDA November 6, 2024
US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab) October 30, 2024
