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The FDAs decision was largely based on data from the SOUL trial, which included data from more than 9,000 patients who were randomized to oral Semaglutide or a placebo, & all patients had type 2 diabetes in addition to known ASCVD , CKD or both

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The FDA sent a warning letter this month to Novo Nordisk, alleging the drugmaker failed to report, in a timely manner, potential side effects in patients who took its popular medications containing semiglutide.

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