Apellis Pharmaceuticals has announced US FDA acceptance of the supplemental new drug application (sNDA) and the granting of ...

The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.

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.

The supplemental New Drug Application for the C3G and IC-MPGN indications is supported by data from the phase 3 VALIANT study.

Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review designation ...

Q4 2024 Earnings Call Transcript March 31, 2025 Omeros Corporation beats earnings expectations. Reported EPS is $-0.54, ...

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 ...

Updated results from the APPEAR-C3G trial – reported at the American Society of Nephrology (ASN) Kidney Week congress in San Diego over the weekend – showed that Fabhalta (iptacopan ...

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 ...