FDA updates in urology: June 2026
A recap of the FDA submissions and regulatory decisions in urology from June 2026.
Welcome to Urology Times’® monthly FDA update! June 2026 brought a wave of regulatory developments across the urology landscape, spanning infectious disease, genitourinary oncology, men's health, imaging, and prosthetic devices. The month's actions included FDA approvals of a new treatment option for complicated urinary tract infections (cUTIs), renal cell carcinoma, and PTEN-deficient metastatic prostate cancer, as well as expanded access to prostate cancer imaging through a generic PSMA-PET radiodiagnostic. Additional highlights included approval of a next-generation inflatable penile prosthesis, tentative approval of generic enzalutamide, and requested testosterone therapy labeling updates that could reshape prescribing considerations for men with age-related hypogonadism.