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On July 23, 2026, an FDA advisory committee voted 86 with one abstention to recommend adding it to the 503A bulks list

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We may learn answers to some of the questions from ongoing randomized controlled trials (e.g., cardiovascular safety trials underway for most approved compounds within the classes of GLP-1 receptor agonists or DPP-4 inhibitors) by analyzing databases or registries better suited for an unbiased postmarketing surveillance of adverse events associated with novel antidiabetes drugs