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.

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 ...

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

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 ...

(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 ...

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

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.

Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...

The label comes with a few important restrictions/caveats that leave room for Apellis’s (APLS) Empaveli to differentiate itself. The firm highlights that Fabhalta is indicated for adults with ...