The EU Just Revoked Tavneos. What Did FDA Know During the Parallel Review?
EMA revoked Tavneos (avacopan) in August 2026 over GCP breaches in the pivotal ADVOCATE trial. FDA approved the same...
Sponsor Accountability
Three Strikes, Same Deficiency: How Elevar Therapeutics Turned a Solvable Manufacturing Problem Into a Patient Crisis
Elevar Therapeutics received its third FDA CRL in two years for rivoceranib plus camrelizumab in liver cancer, each citing...
The CRO Isn’t Failing Your Trial. Your Governance Model Is.
Sponsors treat CRO contract signing as a handoff. Three independent clinical ops leaders say that abdication, not bad molecules,...