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Having a child recipient and helping someone in need – especially if they knew them – were among the top reasons that people ...
From Crohn disease to uncomplicated urinary tract infections and beyond, the FDA issued several high-impact drug approvals last month.
BOSTON, April 10, 2025 (GLOBE NEWSWIRE) -- Folia Health launches enrollment for an innovative, at-home real-world evidence initiative for individuals with C3 glomerulopathy (C3G). Designed in ...
BOSTON, April 10, 2025 (GLOBE NEWSWIRE) -- Folia Health launches enrollment for an innovative, at-home real-world evidence initiative for individuals with C3 glomerulopathy (C3G). Designed in ...
Carla Nester, MD, MSA, FASN, is coinvestigator for the ongoing APPEAR-C3G trial (NCT04817618), data from which were used to support the FDA’s recent approval of iptacopan (Fabhalta; Novartis ...
Amvuttra (vutrisiran) Transthyretin-directed small interfering RNA therapeutic Treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce ...
As targeted treatments such as Tarpeyo (Calliditas), Filspari (Travere), Fabhalta (Novartis), and most recently Vanrafia (Novartis) enter the market, this research captures how patients are ...
A Prescription Drug User Fee Act target date of July 28, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has granted Priority Review to pegcetacoplan for the ...
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 ...
The approval comes just two weeks after Novartis’ oral Fabhalta (iptacopan) was approved by the FDA as the first treatment for the ultra-rare kidney disease complement 3 glomerulopathy. Fabhalta was ...
This is Novartis’s third U.S. approval for its kidney disease portfolio in the last year. Fabhalta was granted FDA approval in C3 glomerulopathy in March 2025 and accelerated approval in IgAN in ...