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FDA Warns Novo Nordisk Over Delayed Adverse Event Reports

3/12/2026

31 5 Full Breakdown

Summary

Story summary

The U.S. Food and Drug Administration (FDA) issued a warning letter to Novo Nordisk A/S on March 5, 2026 for failing to report serious adverse events linked to Ozempic and Wegovy.
The FDA found three deaths were not investigated or reported within required timelines, including one suicide, with reports overdue by over 800 days.
Novo Nordisk A/S has 15 business days to outline corrective actions to prevent future violations.

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Story summary

The U.S. Food and Drug Administration (FDA) issued a warning letter to Novo Nordisk A/S on March 5, 2026 for failing to report serious adverse events linked to Ozempic and Wegovy.
The FDA found three deaths were not investigated or reported within required timelines, including one suicide, with reports overdue by over 800 days.
Novo Nordisk A/S has 15 business days to outline corrective actions to prevent future violations.