FDA asks Amgen to voluntarily pull Tavneos; Amgen declines on January 28

On January 16, 2026 the FDA asked Amgen to voluntarily withdraw TAVNEOS from the U.S. market, citing questions about how certain study data supporting the 2021 approval were analyzed and adjudicated. Amgen told the FDA on January 28 that it did not intend to withdraw the drug, saying it was confident in the drug's effectiveness and benefit-risk profile. This was the first step in a regulatory fight that escalated through April.

• FDA request to voluntarily withdraw TAVNEOS dated January 16, 2026
• Amgen informed the FDA on January 28, 2026 that it did not intend to withdraw
• The FDA questioned the analysis and adjudication of study data behind the October 2021 approval
• TAVNEOS remained on sale while the dispute continued