FDA updates in urology: November 2025

Welcome to Urology Times’® monthly FDA update! November was a busy month for regulatory news in urology, with several key approvals and several more agents coming down the pike. This month’s notable advances included the removal of the “black box” warning label on hormone replacement therapy, as well as the approval of pembrolizumab (Keytruda) plus enfortumab vedotin-ejfv (Padcev) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.

Stay informed with our FDA recap, delivered during the first week of each new month. To stay even more informed on the latest from Urology Times, subscribe to our newsletters!

FDA News in Urology from November 2025

1. FDA approves fosfomycin for complicated urinary tract infections

On November 4, 2025, Meitheal Pharmaceuticals announced FDA approval of fosfomycin (Contepo) for injection for the treatment of adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.¹ The approval was supported by results from the phase 2/3 ZEUS trial (NCT02753946), which demonstrated noninferiority of IV fosfomycin to piperacillin/tazobactam for overall success (clinical cure plus microbiological eradication) in cUTI. Fosfomycin was generally well tolerated, with a safety profile consistent with prior studies.

2. FDA removes warning labels on hormone replacement therapy

On November 10, 2025, the FDA announced plans to remove broad warning labels on hormone replacement therapy (HRT) for menopause.² This action was based on updated evidence reviewed through expert panel input, literature evaluation, and public commentary showing that prior warnings overstated risks and that HRT may offer significant protective benefits when initiated near perimenopause. The agency will retain the boxed warning for endometrial cancer on estrogen-alone products.

3. FDA grants fast track designation to diagnostic agent for clear cell renal cell carcinoma

On November 17, 2025, ITM announced FDA fast track designation for the PET imaging agent [68Ga]Ga-DPI-4452 (ITM-94) for detecting clear cell renal cell carcinoma.³ The agent, alongside its theranostic pair, [177Lu]Lu-DPI-4452 (ITM-91), is currently under investigation in an ongoing, open-label phase 1/2 trial (NCT05706129) in patients with locally advanced or metastatic solid tumors, including ccRCC.

4. FDA grants breakthrough device designation to diagnostic test for cUTIs

On November 18, 2025, Nanopath announced FDA breakthrough device designation for its diagnostic assay for detecting infection in patients with suspected or at-risk cUTIs.⁴ This designation is based on the assay’s potential to significantly improve cUTI diagnosis by delivering molecular results directly from urine within approximately 15 minutes. According to the company, the platform may enable faster, targeted therapy and reduce unnecessary antibiotic use.

5. FDA grants 510(k) clearance to new edition of Focal One robotic HIFU

On November 20, 2025, EDAP announced FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One high-intensity focused ultrasound (HIFU) system for robotic focal therapy in prostate cancer.⁵ The safety and efficacy of Focal One–guided focal ablation has been well-established across several studies, such as showing noninferiority to radical prostatectomy in the randomized FARP trial and favorable functional outcomes in the prospective HIFI trial. The updated system includes advanced imaging, streamlined planning, and an optimized interface, with future potential for AI-driven treatment support.

6. FDA greenlights pivotal trial of gene-editing therapy for PH1

On November 18, 2025, YolTech Therapeutics announced FDA IND clearance to initiate a pivotal trial of YOLT-203, an in vivo gene-editing therapy for primary hyperoxaluria type 1.⁶ The pivotal study will evaluate the therapy’s ability to reduce oxalate overproduction and improve long-term renal outcomes. Early data from a phase 1 trial of the agent (NCT06511349) demonstrated encouraging safety, tolerability, and nearly 70% reductions in urinary oxalate levels in patients treated at the highest dose level.

7. FDA approves pembrolizumab plus enfortumab vedotin for cisplatin-ineligible MIBC

On November 21, 2025, the FDA approved pembrolizumab and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda QLEX), each in combination with enfortumab vedotin as perioperative regimens for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.⁷ The approval was supported by results from the phase 3 KEYNOTE-905/EV-303 trial (NCT03924895), in which the regimen yielded significant improvements in event-free survival, overall survival, and pathological complete response rate compared with surgery alone.

8. FDA grants fast track designation to AVZO-103 for urothelial carcinoma

On November 24, 2025, the FDA granted fast track designation to AVZO-103, a Nectin-4/TROP2 bispecific antibody-drug conjugate for adult patients with urothelial carcinoma who had previously received enfortumab vedotin.⁸ The agent is currently under evaluation in a phase 1/2 clinical trial to assess its safety, tolerability, and preliminary efficacy in this patient population. AVZO-103 is being studied as both a monotherapy and a combination therapy.

REFERENCES

1. Meitheal Pharmaceuticals receives approval from the US Food and Drug Administration for CONTEPO™ (fosfomycin) for injection in patients ≥ 18 years having complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). News release. Meitheal Pharmaceuticals. November 4, 2025. Accessed December 1, 2025. https://www.businesswire.com/news/home/20251104528525/en/Meitheal-Pharmaceuticals-Receives-Approval-from-the-US-Food-and-Drug-Administration-for-CONTEPO-fosfomycin-for-injection-in-Patients-18-Years-Having-Complicated-Urinary-Tract-Infections-cUTI-Including-Acute-Pyelonephritis-AP

2. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. News release. US Food & Drug Administration. November 10, 2025. Accessed December 1, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy-0

3. ITM receives U.S. FDA fast track designation for ITM-94 as a diagnostic agent for clear cell renal cell carcinoma. News release. ITM Isotope Technologies Munich SE. November 17, 2025. Accessed December 1, 2025. https://www.biospace.com/press-releases/itm-receives-u-s-fda-fast-track-designation-for-itm-94-as-a-diagnostic-agent-for-clear-cell-renal-cell-carcinoma

4. Nanopath granted FDA breakthrough device designation for its molecular diagnostic platform for urinary tract infections. News release. Nanopath. November 18, 2025. Accessed December 1, 2025. https://www.prnewswire.com/news-releases/nanopath-granted-fda-breakthrough-device-designation-for-its-molecular-diagnostic-platform-for-urinary-tract-infections-302617775.html

5. EDAP receives FDA 510(k) clearance for latest evolution of Focal One Robotic HIFU. News release. EDAP TMS. November 20, 2025. Accessed December 1, 2025. https://investor.focalone.com/news-releases/news-release-details/edap-receives-fda-510k-clearance-latest-evolution-focal-one

6. YolTech Therapeutics receives FDA IND clearance to initiate global pivotal trial of in vivo gene-editing therapy YOLT-203 for primary hyperoxaluria type 1 (PH1). News release. YolTech Therapeutics. November 18, 2025. Accessed December 1, 2025. https://www.businesswire.com/news/home/20251117980866/en/YolTech-Therapeutics-Receives-FDA-IND-Clearance-to-Initiate-Global-Pivotal-Trial-of-In-Vivo-Gene-Editing-Therapy-YOLT-203-for-Primary-Hyperoxaluria-Type-1-PH1

7. FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer. US Food & Drug Adminstration. November 21, 2025. Accessed December 1, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer?utm_medium=email&utm_source=govdelivery

8. Avenzo Therapeutics granted Fast Track Designation for AVZO-103, a potential best-in-Class Nectin4/TROP2 bispecific antibody-drug conjugate, for the treatment of patients with urothelial cancer previously treated with enfortumab vedotin. News release. Avenzo Therapeutics, Inc. November 24, 2025. Accessed December 1, 2025. https://avenzotx.com/press-releases/avenzo-therapeutics-granted-fast-track-designation-for-avzo-103-a-potential-best-in-class-nectin4-trop2-bispecific-antibody-drug-conjugate-for-the-treatment-of-patients-with-urothelial-cancer-previo/