Farxiga Approved for Patients With CKD at Risk of Progression
The approval was based on data from the DAPA-CKD trial, which compared dapagliflozin, an SGLT2 inhibitor, to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
Urologic Disorders
Bardoxolone Under Review for CKD Caused by Alport Syndrome
The NDA submission includes data from the phase 3 CARDINAL trial that evaluated the efficacy and safety of bardoxolone in 157 patients with CKD caused by Alport syndrome.
COVID-19 Virus Spike Protein Detected in Urine
In a small study, 25% of adults with COVID-19 shed SARS-CoV-2 spike S1 protein in their urine at least once during the course of infection.
Sodium Bicarbonate May Mitigate Calcium Phosphate Stone Risk in CKD
Oral sodium bicarbonate therapy given to patients with chronic kidney disease increases urinary pH but also increases urinary citrate levels, which may mitigate the risk for calcium phosphate stone formation.
Trodelvy Gets Accelerated Approval for Urothelial Cancer
The accelerated approval was based on data from the multicenter, open-label, phase 2 TROPHY study.
Gemtesa Now Available for Overactive Bladder Treatment
Gemtesa is an oral, once-daily, small molecule beta-3 adrenergic agonist.
FDA Clears Point-of-Care Test for Chlamydia, Gonorrhea
The io instrument processes a single-use cartridge that contains all reagents for testing collected vaginal swabs and male urine samples.
Vadadustat NDA Submitted for Anemia Due to Chronic Kidney Disease
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
Myrbetriq Approved for Pediatric Neurogenic Detrusor Overactivity
Both formulations are indicated for patients aged 3 years and older; however, the tablet formulation is specifically approved for patients weighing 35kg or more.
Hormone Therapy May Reduce Nocturia After Menopause
Prevalence of nocturia reduced among postmenopausal women who selected systemic hormone therapy compared with no treatment
