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From Trials to Triumph: 2024’s FDA approvals
Manage episode 461614750 series 3555208
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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
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