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Maroc Maroc - DRUGS.COM - New Drug Approvals - 05/Sep 05:09

Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy

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® (sparsentan) to slow kidney function decline in...

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Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy

drugs.com - 05/Sep 05:09

SAN DIEGO, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration...

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Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

zacks.com - 09/Sep 15:58

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

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Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

zacks.com - 09/Sep 15:58

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

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Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

drugs.com - 03/Sep 01:09

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing...

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FILSPARI (sparsentan) tablet, film coated [Travere Therapeutics, Inc.]

nlm.nih.gov - 10/Sep 04:00

Updated Date: Tue, 10 Sep 2024 00:00:00 EDT

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FILSPARI (sparsentan) tablet, film coated [Travere Therapeutics, Inc.]

nlm.nih.gov - 10/Sep 04:00

Updated Date: Tue, 10 Sep 2024 00:00:00 EDT

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KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

drugs.com - 03/Sep 20:09

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....

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Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug

zacks.com - 04/Sep 15:37

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...