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The REDEFINE 3 cardiovascular outcomes trial which will take several years to complete is not a prerequisite for initial market authorisation for obesity treatment, but its results will likely be important for subsequent label expansion and for establishing the cardiovascular benefit profile that has proven so valuable for tirzepatide and semaglutide

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Claus V, Spleis H, Federer C, Zller K, Wibel R, Laffleur F et al

J Am Acad Dermatol, 32(2/1): 212-217

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FDA Adds New Side Effect Warning to Ozempic Label Popular semaglutide injectable Ozempic will now have a warning about intestinal blockage after the Food and Drug Administration accepted manufacturer Novo Nordisks proposed changes to the drugs packaging