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The statute authorizes the Secretary to make exceptions to the 2 times rule in unusual cases, such as for low-volume items and services (but the Secretary may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act)

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The 2.4 mg group lost the most weight, which means that among adults suffering from overweight or obesity and T2DM, SMG 2.4 mg once a week has achieved significant clinically significant weight loss (99)

and, under accelerated approval, for noncirrhotic MASH with moderate to advanced liver fibrosis in adults

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