Renal & Urology News2d
Fabhalta Approved as First Treatment for C3 Glomerulopathy
The FDA has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.
pharmaphorum16d
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 ...
pharmaphorum3d
Novartis gets FDA nod for second of three IgAN drugs
Vanrafia (atrasentan) is the first drug in the selective endothelin A receptor antagonist (ERA) class to be cleared in the US ...
Fierce Pharma3d
Vanrafia, 2nd drug in Novartis' IgAN troika, crosses FDA finish line in payday for Chinook investors
When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a ...
PMLive12d
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 ...
Zacks Investment Research on MSN4d
APLS' Empaveli sNDA for 2 Rare Kidney Diseases Gets FDA Priority Tag
Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the ...
Medical Dialogues15d
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 ...
WAVY-TV17d
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 ...
Business Insider19d
Fabhalta Shakes Up the PNH Market in 15 Months as Soliris, Ultomiris, and Empaveli Compete and Voydeya and PiaSky Carve Their Niche
The competitive landscape for PNH has seen significant shifts, particularly with the introduction of Fabhalta (Novartis), which launched in December 2023, alongside newer market entrants Voydeya ...
Yahoo Finance15d
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 ...
Monthly Prescribing Reference17d
Fabhalta Approved as First Treatment for C3 Glomerulopathy
Findings from the APPEAR-C3G trial showed a 35% reduction in 24-hour UPCR from baseline (primary endpoint) in the iptacopan group compared with the placebo group. The Food and Drug Administration ...