Browsing Tag
Trutakna
2 posts
Novartis Fabhalta wins first FDA traditional approval to slow IgAN kidney decline
Novartis has won FDA traditional approval for Fabhalta to slow kidney function decline in adults with primary IgA nephropathy, upgrading a 2024 accelerated label into the first full complement-inhibitor claim on eGFR. The decision moves Novartis ahead of Vera Therapeutics' Trutakna, which received only accelerated approval on 7 July, and lands one day before the Novartis Q2 2026 earnings release. The commercial question is whether Fabhalta's oral, disease-modifying label can convert into a durable IgAN franchise against a widening field of complement, endothelin and B-cell targeted therapies.
Vera Therapeutics wins FDA approval for Trutakna as VERA stock jumps
Vera Therapeutics wins FDA approval for Trutakna as VERA stock jumps. Read how launch execution, pricing and full approval risks shape the next phase.