MPR2d
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.
Novartis12d
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) ...
PMLive8d
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 ...
Fierce Pharma11d
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 ...
pharmaphorum12d
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 ...
Managed Healthcare Executive11d
FDA Approves Novartis’ Oral Fabhalta as First Treatment for C3G
The FDA on Thursday approved Fabhalta (iptacopan) to treat complement 3 glomerulopathy (CG3), a progressive, ultrarare kidney ...
Medical Dialogues11d
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 ...
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 ...
Yahoo Finance11d
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 ...
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 ...
Yahoo Finance12d
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 ...
WGHP12d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)
EAST HANOVER, N.J., March 20, 2025 /PRNewswire/ -- Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of ...