FDA Approves Oral Testosterone Replacement Therapy Tlando
The approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients.
Urologic Disorders
Positive Efficacy Findings Prompt Early Stop of Empagliflozin CKD Trial
The EMPA-KIDNEY study enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes.
More Data Needed to Make Decision on Bardoxolone in Alport Syndrome
The CRL stated that the application for bardoxolone could not be approved in its current form due to a lack of data supporting claims of slowing kidney function loss and reducing kidney failure progression.
FDA Clears First Condom Indicated for Anal Intercourse
The FDA authorization was based on efficacy and safety data from a clinical trial that included 252 men who have sex with men and 252 men who have sex with women.
Tebipenem HBr Gets Priority Review for Oral Treatment of Complicated UTI
The application includes data from the phase 3 ADAPT-PO trial, which evaluated the efficacy and safety of tebipenem HBr in 868 adults with cUTI or acute pyelonephritis.
Entadfi Approved for Benign Prostatic Hyperplasia
Entadfi is a fixed-dose combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
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.
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.
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