FDA: No Approval for Bladder Cancer Drug Vicineum
Vicineum is an investigational locally administered recombinant fusion protein that targets EpCAM antigens on the surface of tumor cells to deliver Pseudomonas Exotoxin A.
Miscellaneous Urogenital Disorders
Diagnosis of Inflammatory Arthritis Tied to Impaired Male Fertility
Men diagnosed at age 30 years or younger had a significantly lower mean number of children than those diagnosed at age 31 to 40, 41 years or older
COVID-19 Vaccines Do Not Interfere With Male Fertility
No significant decreases seen in any sperm parameters following two doses of an mRNA COVID-19 vaccine
Generic Version of Thiola Now Available
Tiopronin is indicated for the prevention of cystine stone formation in patients with severe homozygous cystinuria who are unresponsive to treatment with high fluid intake, alkali, and diet modification.
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.
FDA Approves New Formulation of Ultomiris for PNH and aHUS
The FDA has approved a new 100mg/mL formulation of Ultomiris® (ravulizumab-cwvz; Alexion Pharmaceuticals) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and pediatric patients.
FDA Cites Deficiencies in Veverimer NDA for Metabolic Acidosis in CKD
Veverimer is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD.
Orphan Drug Status Granted to Potential Polycystic Kidney Disease Treatment
Autosomal dominant polycystic kidney disease (ADPKD) is caused by mutations of the PKD1 and PKD2 genes.
Recommendations Updated for Barrier Method Use Among Teens
American Academy of Pediatrics policy statement updated recommendations are presented relating to use of barrier methods for adolescents engaging in sexual activity.
