Filspari Granted Accelerated Approval to Reduce Proteinuria in IgA Nephropathy
Sparsentan is an endothelin and angiotensin II receptor antagonist.
Diagnosis & Disease Information
Calciphylaxis Prevention and Treatment Strategies
Calciphylaxis treatment should include a multimodal approach with a focus on supportive care, infection prevention, pain management, and wound healing.
Jesduvroq Approved for Anemia of CKD in Patients on Dialysis
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
Novel Oral Anticoagulant Fast Tracked for Patients With ESRD and Atrial Fibrillation
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
Recall of Sodium Bicarbonate Injection Due to Vial Breakage Expanded
The recalled product was distributed between October 26, 2021 and August 10, 2022.
FDA: Prolia Use in Dialysis Patients May Cause Severe Hypocalcemia
According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis.
FDA Panel Votes on Tenapanor for Hyperphosphatemia in CKD
For patients who tolerated and remained on therapy, the average treatment effect on serum phosphorus was about -0.7mg/dL.
Empagliflozin Cuts Risk of Kidney Disease Progression, CV Death in CKD Patients
The EMPA-KIDNEY trial enrolled more than 6600 patients 18 years of age and older with CKD at risk of kidney disease progression.
FDA Panel Votes on Daprodustat for Anemia of Chronic Kidney Disease
The NDA was supported by data from the ASCEND clinical program, which included dialysis and nondialysis patients.
FDA Needs Additional Time to Review Sparsentan, Tofersen Applications
The target action dates have been extended by 3 months to allow for extra time to review the applications.
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