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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.

Lilly will be launching small molecule orforglipron in late 2026 following an FDA PDUFA date in April, having built over $1bn in inventory as it anticipates high demand

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However, because federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA, many cases are likely going undocumented.FDA has also warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled for research purposes or not for human consumption. These products have been sold directly to consumers for human use with dosing instructions

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