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Nephrology · global

Two-Year Kidney Function Curve Nearly Flat: Voyxact Phase 3 Trial Adds Long-Term Evidence in IgA Nephropathy

Compared with the continued decline in the placebo group, the annualized change in kidney function among patients treated with sibeprenlimab was close to zero. This result will serve as key evidence for converting the US accelerated approval to traditional approval, although full analyses and longer-term clinical outcomes remain to be confirmed.

Drug Regulation · eu

EU Formally Revokes Tavneos Marketing Authorization as Unreliable Pivotal Trial Data Reshape Drug’s Fate

From the recommendation to revoke authorization in June to the final decision, Tavneos has now been listed by the EU as a medicine whose authorization is no longer valid. At the heart of the controversy is not merely an analytical error, but the reassessment of patient data after unblinding, which pushed results that had originally failed to demonstrate superiority past the threshold for statistical significance.