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Syndax’s Revuforj Granted FDA Priority Review for Relapsed/Refractory Mutant NPM1 AMLSyndax Pharmaceuticals Inc. (NASDAQ:SNDX) is one of the most promising stocks according to Wall Street analysts. On June 24, ...
Travere Therapeutics, Inc. 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 ...
The ongoing regulatory approval process carries inherent risks, including the possibility that the FDA may not accept the sNDA for review or grant approval within the anticipated timeline.
PDUFA target action date of January 13, 2026. If approved, FILSPARI would be the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure ...
By streamlining the administration process, ... Key Highlights: FDA-approved sNDA adds a simplified, IV NAC dosing regimen to the product prescribing information.
If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure Additionally, the FDA notified the Company that ...
If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure Additionally, the FDA notified the Company that ...
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