Join us this week for a brief tour of some body systems as we review five medications approved by the FDA in 2024. From liver disease to Alzheimer’s, we look at Rezdiffra, Iqirvo, Vafseo, Entyvio, and Kisunla, exploring the diseases they intend to treat and a brief overview of how the medicines work. We celebrate the hard work of volunteers, investigators, coordinators, and other participants in the clinical trial process.

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References:

Akebia Therapeutics, Inc. (27 March, 2024). Akebia receives FDA approval of Vafseo®... PR Newswire. Link

Chertow, G. M. et al. (2021). Vadadustat in patients with anemia... New England Journal of Medicine, 384(17), 1589-1600. Link

Harrison, S. A. et al. (2024). A phase 3, randomized, controlled trial of resmetirom in NASH with liver fibrosis. New England Journal of Medicine, 390(6), 497-509. Link

Ipsen. (10 June, 2024). Ipsen’s Iqirvo® receives U.S. FDA accelerated approval... Link

Jayaprakash, N., & Elumalai, K. (2024). Translational Medicine in Alzheimer's Disease: The Journey of Donanemab From Discovery to Clinical Application. Chronic Diseases and Translational Medicine.  Link

Kowdley, K. V. et al. (2024). Efficacy and safety of elafibranor in primary biliary cholangitis. New England Journal of Medicine, 390(9), 795-805. Link

Madrial Pharmaceuticals, Inc. (14 March, 2024). Madrigal pharmaceuticals announces FDA approval of Rezdiffra™... Link

Takeda. (18 April, 2024). U.S. FDA approves subcutaneous administration of Takeda’s ENTYVIO®... Link

U.S. Food and Drug Administration. (7 January, 2025). Novel Drug Approvals for 2024. Link

Wyant, T., et al. (2016). An overview of the mechanism of action of the monoclonal antibody vedolizumab. Journal of Crohn's and Colitis, 10(12), 1437-1444. Link