Korsuva Approved for Chronic Kidney Disease-Associated Pruritus
The approval was based on data from the pivotal phase 3 KALM-1 and KALM-2 trials, as well as data from an additional 32 clinical studies.
Urologic Disorders
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.
FDA Denies Approval of Roxadustat for Anemia in CKD
The FDA noted that the application could not be approved in its present form and had requested an additional clinical study be conducted.
FDA Wants Another Study Before Deciding on Tenapanor Approval
Tenapanor inhibits the sodium/hydrogen exchanger 3 to control serum phosphorus in adults with CKD on dialysis.
Study Supports Shorter Antibiotic Course for Afebrile Men With UTI
The double-blinded, placebo-controlled noninferiority study included a total of 272 afebrile men from 2 US Veterans Affairs medical centers.
Kerendia Approved to Reduce CKD Progression, CV Risk in Patients With Diabetic Kidney Disease
The approval was based on data from the phase 3 FIDELIO-DKD trial.
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.
Vaginal pH Regulator Gets Fast Track Status for Gonorrhea Prevention
EVO100 is pH-modulating vaginal gel designed to reduce certain vaginal infections by balancing vaginal pH, thereby maintaining healthy vaginal flora.
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