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...
Rare Disease
The CHMP’s May 2026 Output Signals a Structural Shift in European Drug Development — Sponsors Should Take Notes Now
EMA's CHMP recommended 8 new medicines and 13 indication extensions in May 2026—including camizestrant for ESR1+ breast cancer and...
Favipiravir Just Beat Ribavirin in Lassa Fever—Now Comes the Hard Part
A Phase 2 RCT published in Nature Medicine shows favipiravir cut Lassa fever mortality with HR 0.50—but the regulatory...
The Trial That Should Rewrite the Rare Disease Playbook — But Probably Won’t
AstraZeneca's Phase 3 benralizumab trial in hypereosinophilic syndrome just delivered one of the cleanest efficacy signals in rare disease...
One Biomarker, Two Diseases: The p-tau Signal That Just Complicated Your Stratification Strategy
A multicenter cross-sectional study in Nature Medicine shows serum p-tau—the cornerstone of Alzheimer's blood-based diagnostics—may also detect systemic amyloidoses....