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.
Kidney Disease
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.
Reports of Vial Breakage Prompt Recall of Sodium Bicarbonate Injection
Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton has been recalled due to a potential safety concern with vial breakage and flying glass.
Oxlumo Indication Expanded to Include Patients With Advanced PH1
The approval was based on data from the phase 3 ILLUMINATE-C study that included 21 dialysis-independent and -dependent patients with PH1.
FDA Approves Terlivaz to Improve Kidney Function in Hepatorenal Syndrome
Terlivaz is a vasopressin analogue selective for V1 receptors.
Novel Anticoagulant Therapy for Patients With ESRD Gets Fast Track Status
MK-2060 is an investigational monoclonal antibody designed to inhibit the activation of Factor XI and its ability to activate downstream proteins.
Therapeutic Peptide Granted Orphan Drug Status for Hepatorenal Syndrome
The Company is currently evaluating OCE-205 in a phase 2 trial in adults who have developed hepatorenal syndrome with acute kidney injury.
FDA Clears Bodyport Cardiac Scale to Monitor Heart Function, Fluid Status
The Bodyport Cardiac Scale is designed to detect signals through an individual’s feet to noninvasively measure a broad spectrum of hemodynamic biomarkers for heart function and fluid status.
Eating Nuts Tied to Lower Prevalence of Chronic Kidney Disease
Consumption of nuts also linked to lower all-cause and cardiovascular mortality in non-CKD population
