Die US-Arzneimittelbehörde FDA hat den ergänzenden Zulassungsantrag (sNDA) des Unternehmens für Sparsentan zur Behandlung von FSGS, einer seltenen Nierenerkrankung, angenommen. Laut ...

The expectation of a standard review timeline delays the potential market introduction of Sparsentan to the following year, which diverges from what the market was expecting. Despite these challenges, ...

The expectation of a standard review timeline delays the potential market introduction of Sparsentan to the following year, which diverges from what the market was expecting. Despite these ...

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (NDA) for sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).

The two-year results from the study were published in the New England Journal of Medicine and showed that sparsentan delivered clinically meaningful benefit at 108 weeks with significant ...

for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date ...

BOSTON — Sparsentan, a first-in-class, oral dual endothelin-angiotensin receptor antagonist, shows significant benefit in reducing proteinuria in the difficult-to-manage focal segmental ...

The late-breaking oral presentation will feature new analyses from the Phase 3 DUPLEX Study of FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), showing that partial and ...

The two-year results from the study were published in the New England Journal of Medicine and showed that sparsentan delivered clinically meaningful benefit at 108 weeks with significant ...

seeking priority review for traditional approval of FILSPARI ® (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The submission is supported by results from the Phase 3 ...