PDUFA Date
PDUFA Date: filspari
- Drug
- filspari
- Indication
- Company completed a Type C meeting with FDA and plans to submit an sNDA for traditional approval of FILSPARI in FSGS based on existing Phase 2 and 3 data.
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Phase 3 ReadoutPhase 3 Topline: A Phase 3, Parallel-Group Treatment, Blinded, Randomized, Placebo-Controlled Study To Assess The Eff
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Phase 3 ReadoutPhase 3 Topline: REVERsal to Normoglycemia by Treating PREDIABETES: The REVERT-PREDIABETES Trial
Phase 3 ReadoutPhase 3 Topline: An Open-Label, Phase 3 Long-Term Extension (LTE) Study To Assess The Safety, Tolerability, And Effic
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