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Iptacopan News

Novartis Receives Third FDA Approval for Oral Fabhalta (iptacopan), the First and Only Treatment Approved in C3 Glomerulopathy

Basel, March 20, 2025 – Novartis today announced that oral Fabhalta (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), ...

Novartis Receives FDA Accelerated Approval for Fabhalta (iptacopan) for the Reduction of Proteinuria in Primary IgA Nephropathy (IgAN)

Basel, August 8, 2024 – Novartis today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for t...

FDA Approves Fabhalta (iptacopan) for the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Basel, December 6, 2023 — Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with pa...

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Further information

Iptacopan patient information at Drugs.com