MPR1d
Fabhalta Approved as First Treatment for C3 Glomerulopathy
The approval of iptacopan in reducing proteinuria in adult patients with native kidney C3G was based on data from the randomized, double-blind, placebo-controlled, phase 3 APPEAR-C3G trial.
pharmaphorum8d
Fabhalta is first FDA-approved therapy for rare disease C3G
Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...
PMLive4d
Novartis’ Fabhalta granted FDA approval to treat ultra-rare kidney disease C3G
Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for ...
MedPage Today8d
First Drug Approved for Ultra-Rare Kidney Disease
Opens in a new tab or window The FDA approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in adults with complement 3 glomerulopathy (C3G), the agency announced Thursday.
MedCity News6d
Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels
The March 20 approval of Fabhalta covers the treatment of adults with C3 glomerulopathy (C3G), a disease affecting glomeruli, tiny blood vessels in the kidney responsible for filtering waste from ...
PharmExec5d
FDA Approves Novartis’ Fabhalta for C3 Glomerulopathy
The FDA has approved Novartis’ Fabhalta (iptacopan) as the first and only treatment for C3 glomerulopathy (C3G). Previously, patients with C3G were forced to rely on supportive care and broad ...
Novartis8d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
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) ...
Fierce Pharma8d
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
Medical Dialogues7d
FDA Approves First oral Treatment for rare Glomerulopathy
The US Food and Drug Administration (FDA) has approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in ...
BioSpace8d
Novartis’ Fabhalta Approved as First Therapy for Rare Kidney Disease
This is the third indication for Fabhalta after Novartis won FDA approval of the small molecule in paroxysmal nocturnal ...
MyChesCo on MSN5d
FDA Unveils Life-Changing Drug, Urgent Device Alert, and Revolutionary Tech to Protect Your Health
The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing ...