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The FDA approval process is a rigorous and lengthy process that involves evaluating the safety and effectiveness of a medication for a specific use

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Dosing and Administration Currently orally administered semaglutide is approved by the US Food and Drug Administration (FDA), European Medicines Agency, Health Canada, Australia and Japan as an adjunct to diet and exercise to improve glycaemic control in adults with T2DM

This is a side effect to monitor as more Phase 3 data becomes available, though it does not appear to be a major tolerability concern based on the initial data

Questions remain about how the drug works and for whom The new study results flesh out earlier news of the trial released by funder Novo Nordisk in August (SN: 8/29/23 )