Drug approval process stories

Jun 29, 2026

New England Journal of Medicine Retracts Amgen's Tavneos Clinical Trial Amid Data Manipulation Allegations

The New England Journal of Medicine retracted the main clinical trial used to approve Amgen's $500 million drug Tavneos, following allegations of data manipulation. The European Medicines Agency had previously recommended revoking the drug's approval over data integrity concerns.

Jun 29, 2026·1 source

May 4, 2026

FDA Rejects Promising Melanoma Drug RP1 Twice, Raising Concerns About Drug Approval Process

The FDA has rejected RP1, a breakthrough melanoma treatment, twice despite its promise in treating skin cancer. The rejections have left medical professionals puzzled and concerned about implications for future drug approvals.

May 4, 2026·1 source

Top claims

▪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.
▪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.

Subtopics

Drug safety Scientific misconduct Cancer treatment Healthcare Policy

Related timelines

Drug approval process stories

New England Journal of Medicine Retracts Amgen's Tavneos Clinical Trial Amid Data Manipulation Allegations

FDA Rejects Promising Melanoma Drug RP1 Twice, Raising Concerns About Drug Approval Process

Related timelines

Iran War

US Congress

Venture capital funding

Strait of Hormuz blockage

Trump administration