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.
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.
The EMPA-KIDNEY study enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes.
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.
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.
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 is a fixed-dose combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
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.
Vicineum is an investigational locally administered recombinant fusion protein that targets EpCAM antigens on the surface of tumor cells to deliver Pseudomonas Exotoxin A.
The FDA noted that the application could not be approved in its present form and had requested an additional clinical study be conducted.
Tenapanor inhibits the sodium/hydrogen exchanger 3 to control serum phosphorus in adults with CKD on dialysis.