Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the ...

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

SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and ...

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

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Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Empaveli (pegcetacoplan) for two rare and severe kidney ...

sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare kidney ...

We have great hope to potentially bring FILSPARI as the first approved treatment for patients with FSGS and this sNDA submission is an important next step toward that goal. We look forward to the ...