FDA flags Novo Nordisk for unreported side effects tied to Ozempic and Wegovy

TL;DR Summary
The FDA sent Novo Nordisk a warning for serious lapses in reporting potential adverse events linked to semaglutide (the active ingredient in Ozempic and Wegovy), citing three deaths including a suicide and saying the company failed to investigate or report them within required timelines after an inspection of a New Jersey facility. Novo Nordisk says it will address the concerns, and the agency gave two weeks to outline corrective actions.
- FDA warns Novo Nordisk of potential unreported GLP-1 side effects NBC News
- FDA Warns Novo Nordisk Over Potential Unreported Ozempic Side Effects, Deaths Forbes
- FDA Warning Letter Puts Novo Nordisk Compliance And Valuation In Focus Yahoo Finance
- Novo Nordisk is warned by the FDA for failing to report potential side effects tied to GLP-1 drugs statnews.com
- Novo Nordisk receives FDA warning linked to US inspection in 2025 Reuters
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