PharmExec3h
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 ...
MyChesCo on MSN1d
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 ...
Novartis3d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
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 ...
Zacks Investment Research on MSN3d
FDA Approves Novartis Drug for Rare Kidney Disease Treatment
Novartis NVS announced that the FDA has approved Fabhalta (iptacopan) for a third indication. The regulatory body approved ...
Fierce Pharma3d
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 ...
Morgan Stanley says Fabhalta’s label leaves opportunity for Apellis’ Empaveli
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 ...
BioSpace3d
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 ...
Medical Dialogues2d
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 ...
MPR3d
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.
Fabhalta Shakes Up the PNH Market in 15 Months as Soliris, Ultomiris, and Empaveli Compete and Voydeya and PiaSky Carve Their Niche
Spherix Global Insights recently released its latest findings from RealTime Dynamixâ„¢: Paroxysmal Nocturnal Hemoglobinuria Q1 2025 (US) an independent tracking study based on insights from 51 U.S.
Novartis gets third FDA approval for oral Fabhalta
Novartis (NVS) announced that oral Fabhalta, iptacopan, has received U.S. Food and Drug Administration approval for the ...
FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...