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 ...

Fabhalta, discovered at Novartis, received FDA approval in December 2023 for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and accelerated approval in August 2024 for the ...

The Food and Drug Administration (FDA) has approved Fabhalta ® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta is a Factor B inhibitor of the ...

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 today presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan), an investigational Factor B inhibitor of the alternative ...

Novartis' Fabhalta (iptacopan) receives FDA accelerated approval as a first-in-class complement inhibitor for IgA nephropathy, reducing proteinuria in adults at risk of rapid disease progression ...

Contacts Benito Fernandez, Chief Commercial Officer Benito.Fernandez@Onco360.com 516-640-1332 ...

EAST HANOVER, N.J., Dec. 10, 2023 /PRNewswire/ -- Novartis today announced results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta ® (iptacopan) in ...

FABHALTA is a prescription medicine used to treat adults with a kidney disease called complement 3 glomerulopathy (C3G), to reduce protein in the urine (proteinuria).

Fabhalta, the only oral Factor B inhibitor of the alternative complement pathway, has potential to be the first US Food and Drug Administration (FDA) approved treatment for C3G. 2,4,5 Regulatory ...

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 ...