News

Zacks.com on MSN5mon
Novartis Announces Positive Results From Late-Stage Study on Fabhalta
Novartis NVS announced positive top-line results from a late-stage study on Fabhalta (iptacopan) in adult patients with ...
Morningstar2mon
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 ...
Seeking Alpha10mon
Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)
East Hanover, N.J., Aug. 7, 2024 /PRNewswire/ -- Novartis today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta ® (iptacopan), a first-in ...
pharmaphorum2d
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 a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).
FiercePharma2mon
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Novartis’ kidney disease troika keeps marching forward. With a new FDA approval, the company’s Fabhalta has become the first treatment endorsed by the agency for the ultrarare kidney disease ...
Yahoo Finance7mon
Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial
EAST HANOVER, N.J., Oct. 26, 2024 /PRNewswire/ -- Novartis today presented 12-month ... treated with oral Fabhalta ® (iptacopan) in addition to supportive care experienced clinically meaningful ...
FiercePharma10mon
Novartis' IgAN ambition takes shape with expanded FDA nod for Fabhalta
The FDA Wednesday granted an accelerated approval to Novartis’ Fabhalta in IgAN. The complement factor B inhibitor, plus the endothelin A receptor antagonist atrasentan and the anti-APRIL ...
MedCity News2mon
Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels
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.
Benzinga.com2mon
FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
The FDA approved Novartis' Fabhalta, making it the first and only treatment for adults with C3 glomerulopathy. Fabhalta showed sustained proteinuria reduction in Phase 3 trials, with effects seen ...
Longview News-Journal10mon
Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)
Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs ...