Novo Nordisk Stock (NVO) Dives After FDA Scolds the Pharma Giant

Shares of Novo Nordisk NVO -3.04% ▼ are down 4% in afternoon trading on March 10 after the U.S. Food and Drug Administration issued a sharp rebuke of the European pharmaceutical giant.

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Specifically, the FDA sent Novo Nordisk a warning letter for failing to adequately disclose adverse drug effects in the marketing of its medications. The FDA letter dated March 5 accuses Novo Nordisk of serious violations when it comes to the reporting of adverse drug experiences related to its medications that include semaglutide, liraglutide, nedosiran sodium, and estradiol.

The FDA cited the company for failing to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences. The agency found that Novo Nordisk and its contractors failed to report serious and unexpected adverse events to the FDA within the required 15-day timeframe.

According to the warning letter, the company’s written procedures allowed adverse events to be rejected or cancelled if reporters believed they were unrelated to the product, which is inconsistent with FDA regulations. The FDA identified multiple cases where serious adverse events, including stroke, death, and suicidal ideation, were not reported within the required timeframe or were invalidated despite having valid patient identifiers.

The FDA also found that Novo Nordisk failed to promptly investigate adverse events that were subject to 15-day alert reports, partly due to an unnecessary requirement to obtain consent from reporters before conducting follow-up.

Novo Nordisk has submitted multiple responses to the FDA between March 2025 and January 2026, describing corrective actions including revising procedures, conducting retrospective reviews of cases, and transitioning safety case intake to dedicated insourced patient safety agents. However, the FDA deemed these responses inadequate, stating the company did not provide sufficient details to determine whether the actions would prevent similar violations in the future.

The FDA has requested a response within 15 business days outlining actions taken to prevent similar violations.

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