FDA grants accelerated approval for Novartis's Vanrafia (atrasentan) for IgA nephropathy. The drug joins Tarpeyo and Filspari ...
Vanrafia (atrasentan) is the first drug in the selective endothelin A receptor antagonist (ERA) class to be cleared in the US for IgAN, a disease characterised by the accumulation of antibodies in the ...
The approval is supported by a prespecified interim analysis from the ongoing, randomised Phase III ALIGN trial.
IgAN is a progressive, rare kidney disease in which the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria.
The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.
Learn more about whether Corcept Therapeutics Incorporated or Novartis AG is a better investment based on AAII's A+ Investor ...
Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.
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.
While Novartis holds a diversified product portfolio, there is some product concentration with its largest drugs, Entresto (close to 15% of sales) and Cosentyx (close to 10% of sales). Both drugs will ...
The development of advanced radiotherapy technologies has, in turn, resulted in an increased complexity of operations. Also, a high level of accuracy is needed at every step of the process to achieve ...
Vykat XR is specifically indicated to address hyperphagia, or the abnormally strong sensation of hunger, which often leads to ...
Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for ...
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