FDA proposes withdrawing Tavneos approval over manipulated pivotal trial results

The FDA's drug center proposed on April 27, 2026 to withdraw approval of TAVNEOS, and a Federal Register notice followed on April 30. The agency says unblinded study personnel manipulated results of the pivotal trial and that the original analysis was not disclosed to it. Amgen says it remains confident in the drug, and TAVNEOS stays on the market while the hearing process runs, so the near-term revenue risk depends on the outcome of that process.

• CDER proposal to withdraw approval dated April 27, 2026; Federal Register notice April 30, 2026
• FDA says unblinded study personnel manipulated pivotal trial results
• FDA also cites new information showing a lack of substantial evidence of effectiveness
• TAVNEOS remains on the market until the applicant removes it or the FDA Commissioner orders removal
• Amgen says it remains confident in TAVNEOS as safe and effective