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

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

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

The Prescription Drug User Fee Act (PDUFA) target action date is July 28, 2025. “EMPAVELI demonstrated clinically meaningful benefits across all three key markers of disease – unprecedented ...

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

EMPAVELI, which is already approved for paroxysmal nocturnal hemoglobinuria (PNH), has shown promise in Phase 3 VALIANT study results, achieving statistically significant improvements in ...

Empaveli (pegcetacoplan) is a prescription drug that treats paroxysmal nocturnal hemoglobinuria (PNH) by preventing the destruction of red blood cells in your blood vessels, liver, and spleen.

(RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) Tuesday said that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the supplemental New Drug Application ...

WALTHAM, Mass. - The U.S. Food and Drug Administration (FDA) has accepted Apellis Pharmaceuticals, Inc.’s (NASDAQ: APLS) supplemental New Drug Application (sNDA) and granted Priority Review ...

Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.