The New England Journal of Medicine retracted the pivotal clinical trial for Amgen's drug Tavneos on June 29, 2026, after an FDA investigation found data from nine patients were altered post-database lock and researchers were improperly unblinded. Two study authors requested the retraction, jeopardizing the drug's market authorization and future sales.
NEJM retraction
- ▪The New England Journal of Medicine retracted a clinical trial for Amgen Inc.'s drug Tavneos on June 29, 2026
- ▪Two of the Tavneos clinical trial study's authors requested the retraction from the New England Journal of Medicine
- ▪The retracted Tavneos clinical trial was the main study used to approve the drug
FDA data manipulation investigation
- ▪The US Food and Drug Administration investigation found that results of nine patients in the Tavneos trial were changed after the study's database was finalized
- ▪The FDA investigation found that some researchers in the Tavneos trial were unblinded, meaning they were told which patients received the experimental drug and which did not
Tavneos approval status
- ▪The retraction of the Tavneos clinical trial puts the drug's continued sales at risk
- ▪The retracted Tavneos clinical trial was the main study used to approve the drug
- ▪Tavneos is a pill manufactured by Amgen Inc.
Story comments
Loading comments…