Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for ...

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.

The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing ...

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 ...

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...

The affirmative regulatory decision is the third for Novartis’s Fabhalta, building up the drug’s pipeline-in-a-product potential. But competition looms from a rival drug taking a similar approach.

Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...

Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...

This is the third indication for Fabhalta after Novartis won FDA approval of the small molecule in paroxysmal nocturnal ...

The US Food and Drug Administration (FDA) has approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in ...

Morgan Stanley analyst Judah Frommer notes that Novartis (NVS) has received FDA approval for Fabhalta for C3G. The label comes with a few important restrictions/caveats that leave room for Apellis’s ...