Regulatory recap: FDA approvals in urology from the first half of 2025

The first half of 2025 ushered in several FDA approvals across urology, reflecting the growing momentum and innovation in the space. With key FDA nods across bladder cancer, prostate cancer, incontinence, and more, the treatment landscape continues to evolve across a broad range of conditions.

Take a look through all the regulatory milestones in urology from the first half of the 2025.

The first half of 2025 saw several key FDA approvals across urology,

1H Approvals in Urology

FDA clears chemiluminescence-based immunoassay for free testosterone

Date: January 10, 2025

Company: EUROIMMUN

Summary: On January 10, 2025, the FDA granted 510(k) clearance to EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for the quantitative measurement of free testosterone in serum or plasma. With its ability to deliver results in 48 minutes and its use of highly specific monoclonal antibodies, the test provides diagnostic insights for conditions such as hypogonadism, impotence, and polycystic ovarian syndrome. This marked the first FDA-cleared test for direct free testosterone measurement.

FDA grants 510(k) clearance to AI-powered prostate cancer diagnostic

Date: February 10, 2025

Company: Ibex Medical Analytics

Summary: On February 10, 2025, the FDA granted 510(k) clearance to Ibex Prostate Detect, an AI-powered digital pathology software for detecting prostate cancer in tissue biopsies. This decision was based on validation studies showing a 99.6% positive predictive value for heatmap accuracy, as well as data showing that pathologists diagnosing without AI missed 13% of the cancer cases that were identified by the AI. This marked Ibex’s first FDA clearance.

FDA approves PET imaging product Gozellix for prostate cancer

Date: March 20, 2025

Indication: PET imaging of patients with suspected prostate cancer metastases or recurrence

Company: Telix Pharmaceuticals

Summary: On March 20, 2025, the FDA approved Gozellix (TLX007-CDx), a proprietary cold kit for the preparation of gallium-68 (68Ga) gozetotide injection, Telix Pharmaceuticals announced. The PET product is indicated for patients with suspected prostate cancer metastases or recurrence. Telix expects Gozellix to enhance PSMA-PET imaging availability and affordability while complementing its first-generation product, Illuccix.

FDA approves gepotidacin for uncomplicated UTI

Date: March 25, 2025

Indication: Treatment of uncomplicated urinary tract infections (uUTIs) in female adults and adolescents (12 years and older, 40 kg and over)

Company: GSK

Summary: On March 25, 2025, the FDA approved gepotidacin (Blujepa) for the treatment of uUTIs in female adults and adolescents (12 years and older, 40 kg and over), GSK announced. Gepotidacin is the first new oral antibiotic for uUTIs in nearly 30 years. The approval is based on the phase 3 EAGLE-2 and EAGLE-3 trials, where gepotidacin showed non-inferiority and superiority, respectively, to nitrofurantoin, a standard uUTI treatment. GSK plans to launch Blujepa in the US in the second half of 2025.

FDA approves expanded label for ¹⁷⁷Lu-PSMA-617 in mCRPC

Date: March 28, 2025

Indication: Patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy

Company: Novartis

Summary: On March 28, 2025, the FDA approved an expanded indication for ¹⁷⁷Lu-PSMA-617 (Pluvicto) to include patients with PSMA-positive mCRPC in the pre-chemotherapy setting. The approval was supported by data from the phase 3 PSMAfore trial (NCT04689828), which showed that ¹⁷⁷Lu-PSMA-617 significantly prolonged radiographic progression-free survival (rPFS) compared to a change in ARPI. Specifically, the median rPFS was 11.6 months with ¹⁷⁷Lu-PSMA-617 vs 5.6 months with a change in ARPI.

FDA approves durvalumab/chemo for muscle–invasive bladder cancer

Date: March 28, 2025

Indication: Adult patients with muscle-invasive bladder cancer (MIBC)

Company: AstraZeneca

Summary: On March 28, 2025, the FDA approved perioperative durvalumab (Imfinzi) in combination with neoadjuvant chemotherapy for adults with MIBC. The approval was based on findings from the phase 3 NIAGARA trial (NCT03732677), which showed that perioperative durvalumab with neoadjuvant chemotherapy significantly improved event-free survival and overall survival compared to neoadjuvant chemotherapy alone. Safety measures were also comparable between both arms.

FDA grants 510(k) clearance to Glean Urodynamics System

Date: April 2, 2025

Company: Bright Uro

Summary: On April 2, 2025, Bright Uro announced FDA 510(k) clearance for the Glean Urodynamics System for the evaluation of lower urinary tract dysfunction in adults. The device enables wireless, catheter-free ambulatory urodynamics monitoring that can provide improved patient comfort and more physiologically accurate data compared with previous options, Bright Uro reported.

FDA clears stapler for use with da Vinci SP surgical system

Date: April 10, 2025

Indication: For use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures

Company: Intuitive Surgical

Summary: On April 10, 2025, Intuitive Surgical announced FDA 510(k) clearance for the SureForm 45 stapler for use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures. The stapler is designed for use in conjunction with Intuitive’s single-port surgical system, da Vinci SP, which is cleared in the US for urologic, transoral otolaryngology, colorectal, and thoracic procedures.

FDA clears AI-powered application for measuring prostate volume

Date: April 25, 2025

Company: Clarius Mobile Health

Summary: On April 25, 2025, Clarius Mobile Health announced FDA clearance for Clarius Prostate AI, an application that measures prostate volume during handheld ultrasound exams. The tool is activated using a smartphone or tablet, where it then highlights the prostate and places calipers that can be manually adjusted. This application adds to Clarius’ product portfolio, which also includes Bladder AI for measuring bladder volume.

FDA approves darolutamide in metastatic castration-sensitive prostate cancer

Date: June 3, 2025

Indication: Adult patients with metastatic castration-sensitive prostate cancer (mCSPC)

Company: Bayer

Summary: On June 3, 2025, Bayer announced that the FDA approved darolutamide (Nubeqa) for the treatment of adult patients with mCSPC. The approval is supported by results from the phase 3 ARANOTE trial (NCT04736199), which found that darolutamide plus androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival compared with ADT alone. This approval makes darolutamide the first androgen receptor inhibitor indicated for mCSPC with or without chemotherapy.

FDA approves label expansion for Rezūm Water Vapor Thermal Therapy for BPH

Date: June 11, 2025

Indication: Patients with benign prostatic hyperplasia (BPH) with prostate volumes up to 150 g

Company: Boston Scientific

Summary: On June 11, 2025, the FDA cleared a 510(k) label expansion for the Rezūm System, raising the maximum prostate volume that can be treated with the device from 80 g to 150 g for patients with BPH. The expanded indication is supported by a meta-analysis and prospective trial data showing comparable safety and efficacy of Rezūm Water Vapor Thermal Therapy in larger glands.

FDA approves mitomycin intravesical solution for recurrent LG-IR-NMIBC

Date: June 12, 2025

Indication: Adult patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC)

Company: UroGen Pharma

Summary: On June 12, 2025, UroGen announced FDA approval of mitomycin for intravesical solution (Zusduri; formerly UGN-102) for the treatment of adult patients with recurrent LG-IR-NMIBC. The approved was backed by results from the phase 3 ENVISION trial (NCT05243550), which demonstrated a 78% complete response rate at 3 months and durable responses through 18 months. This marks the first FDA-approved medication in this disease setting.

FDA does not approve talazoparib plus enzalutamide for non-HRR gene mutated mCRPC

Date: June 13, 2025

Indication: Broader use in the treatment of patients with non-HRR gene mutated mCRPC

Company: Pfizer

Summary: On June 13, 2025, Pfizer announced that the FDA declined to approve expanded labeling for talazoparib (Talzenna) plus enzalutamide (Xtandi) to include use in patients with non–HRR gene-mutated mCRPC. Overall, the agency sided with a negative decision from the Oncologic Drugs Advisory Committee, determining that data from the phase 3 TALAPRO-2 trial (NCT03395197) were insufficient to support expanded use in this indication. However, the agency did approve updated labeling for the combination’s existing indication to reflect final OS results in HRR gene-mutated mCRPC.

FDA approves integrated sacral neuromodulation system for urinary urge incontinence

Date: June 18, 2025

Indication: Urinary urge incontinence (UUI)

Company: Neuspera Medical

Summary: On June 18, 2025, Neuspera Medical announced FDA clearance of its integrated sacral neuromodulation system for the treatment of patients with UUI. The approval was based on results from the phase 2 SANS-UUI trial (NCT04232696), in which 84.2% of patients achieved at least a 50% reduction in urgent leaks.

FDA expands Illuccix label to include patient selection for RLT in pre-taxane setting

Date: June 23, 2025

Indication: Expanded use in patient selection for PSMA-targeted radioligand therapy in patients with prostate cancer who have not received taxane-based chemotherapy

Company: Telix Pharmaceuticals

Summary: On June 23, 2025, Telix Pharmaceuticals announced that the FDA approved a label expansion for Illuccix (kit for the preparation of gallium Ga-68 gozetotide) to include use in patient selection for PSMA-targeted radioligand therapy in patients with prostate cancer who have not yet received taxane-based chemotherapy. This update aligns with the March 2025 FDA approval of ¹⁷⁷Lu-PSMA-617 (Pluvicto) for earlier use in pre-taxane mCRPC.