Drugs

Filspari sNDA Accepted for Rare Kidney Disease

FDA has accepted for review a Travere Therapeutics supplemental NDA for traditional approval of Filspari (sparsentan) for treating focal segmental glomerulosclerosis (FSGS), a rare and serious kidney disorder. The agency has set a review action target date of 1/13/2026, and told the company that it plans to convene an advisory committee meeting to review the application.

Filspari is a non-immunosuppressive, oral therapy that targets kidney podocyte injury by blocking both the endothelin A receptor and angiotensin II subtype 1 receptor. It is currently approved to slow kidney function decline in patients with immunoglobulin A nephropathy.

The company says the submission is backed by data from the Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrated that Filspari achieved significant and sustained reductions in proteinuria — a key marker of kidney disease progression — compared to standard therapy irbesartan. Although the DUPLEX study did not meet its primary endpoint related to kidney function decline over 108 weeks, it did show significant clinical benefits, including a lower rate of progression to end-stage kidney disease, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome