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Travere Therapeutics anticipates FILSPARI approval for FSGS by ...FILSPARI's net sales grew sequentially by 13%, reflecting continued momentum post-full approval in IgAN. The previous quarter's focus on label expansion has shifted towards leveraging this broader ...
SAN DIEGO, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to FILSPARI ...
Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25 If approved, FILSPARI could be the first and only approved medicine ...
In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases ...
After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in ...
The FDA has converted Filspari’s conditional nod in the kidney disease IgA nephropathy (IgAN) into a full approval. As part of the conversion Thursday, the FDA has removed a specific urine ...
Filspari’s mechanism of action is to treat IgA nephropathy by blocking these two hormones. By blocking so, Filspari helps slow kidney damage. It also may reduce the amount of protein in your urine.
The Food and Drug Administration (FDA) has granted full approval to Filspari ® (sparsentan) to slow kidney function decline in adults with primary immunoglobulin A (IgA) nephropathy who are at ...
--Travere Therapeutics, Inc., today announced that the U.S. Food and Drug Administration has granted full approval to FILSPARI ® to slow kidney function decline in adults with primary IgAN who ...
Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia.
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