The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.
IgAN is a progressive, rare kidney disease in which the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria.
Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.
It currently has no approved treatments. In APPEAR-C3G, Novartis' targeted factor B inhibitor, given on top of standard care, resulted in a "clinically meaningful" reduction in protein in the ...
Novartis' oral complement inhibitor Fabhalta has become the first approved treatment for rare kidney disease C3G as it chases a $3bn sales target.
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 ...
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 ...
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.
The Price to Earnings (P/E) ratio, a key valuation measure, is calculated by dividing the stock's most recent closing price by the sum of the diluted earnings per share from continuing operations ...