FDA updates in urology: March 2026

Welcome to Urology Times’® monthly FDA update! Regulatory updates in March spanned a broad range of urologic indications, with key approvals across prostate cancer, bladder cancer, and benign prostatic hyperplasia (BPH). A notable trend was the refinement or expansion of existing therapies, underscoring an ongoing commitment to patient-centered care.

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FDA news in urology from March 2026

1. FDA approves Pylarify TruVu formulation of PSMA-PET agent piflufolastat F18

On March 6, 2026, Lantheus announced FDA approval of Pylarify TruVu (piflufolastat F 18) injection, a new formulation of its prostate-specific membrange antigen (PSMA)-PET imaging agent for use in prostate cancer.¹ Piflufolastat F 18 injection was initially approved in the US in May 2021 based on data from the phase 2/3 OSPREY (NCT02981368) and phase 3 CONDOR (NCT03739684) trials. The updated formulation is designed to improve product stability at higher radioactive concentrations, enabling more efficient manufacturing, broader distribution, and expanded patient access. Commercial availability of Pylarify TruVu is expected in Q4 of 2026.

2. FDA receives resubmitted sBLA for NAI plus BCG in papillary NMIBC

On March 9, 2026, ImmunityBio announced FDA acknowledgment of a resubmitted supplemental biologics license application (sBLA) for nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG to expand its indication to patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with papillary tumors.² NAI is currently approved in combination with BCG for adult patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors.

The resubmitted sBLA is based on long-term data from cohort B of the phase 2/3 QUILT-3.032 trial (NCT03022825), which demonstrated a 12-month disease-free survival rate of 58.2% with durable bladder preservation and a favorable safety profile.

3. FDA grants 510(k) clearance to Urocross Expander System for BPH-related LUTS

On March 16, 2026, Prodeon Medical announced FDA 510(k) clearance for the Urocross Expander System for the management of lower urinary tract symptoms secondary to BPH.³ The approval was supported by findings from the Expander-1 feasibility trial and Expander-2 pivotal trial. In Expander-2, the System demonstrated a 74.5% responder rate at 12 months and no device-related serious adverse events, with preservation of sexual function. The non-permanent implant is designed for temporary placement and retrieval, offering a minimally invasive option that maintains future treatment flexibility.

4. FDA approves accelerated thawing method for nadofaragene in NMIBC

On March 24, 2026, Ferring Pharmaceuticals announced FDA approval of a label update for nadofaragene firadenovec-vncg (Adstiladrin) to introduce an accelerated thawing protocol for patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ.⁴ This approval is based on a thawing and handling study demonstrating maintained product integrity with thawing in a 25 °C (77 °F) water bath over approximately 25 minutes. The updated protocol is expected to streamline intravesical preparation and improve clinical workflow efficiency without altering storage conditions post-thaw.

5. FDA grants clearance to Asurys Fluid Management System for endoscopic urologic procedures

On March 30, 2026, Boston Scientific announced FDA 510(k) clearance for the Asurys Fluid Management System to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopy.⁵ The system is designed to automatically adjust irrigation flow based on real-time intrarenal pressure (IRP) readings obtained from the LithoVue Elite Single-Use Digital Flexible Ureteroscope with IRP monitoring. In addition to ureteroscopy, the system is also designed to be a single irrigation management system for cystoscopy, percutaneous nephrolithotomy, and BPH procedures.

6. FDA clears neuromuscular stimulation device for post-prostatectomy incontinence

On March 31, 2026, Elidah announced FDA 510(k) clearance for Elitone for Men, a non-invasive neuromuscular stimulation device for the management of urinary incontinence following prostate surgery.⁶ The approval is based on clinical data demonstrating accelerated continence recovery among patients who received the device compared with patients in the control arm. Patients in the treatment arm also experienced a 92% mean reduction in 24-hour pad weight at 12 weeks vs 68% in controls. The at-home device delivers daily pelvic floor stimulation to improve muscle strength and bladder control, with anticipated over-the-counter availability in April 2026.

REFERENCES

1. Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection. News release. Lantheus Holdings, Inc. March 6, 2026. Accessed April 1, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f

2. ImmunityBio announces resubmission of supplemental BLA to the FDA for Anktiva plus BCG in BCG-unresponsive NMIBC with papillary disease following agency review of additional data. News release. ImmunityBio. March 9, 2026. Accessed April 1, 2026. https://immunitybio.com/immunitybio-announces-resubmission-of-supplemental-bla-to-the-fda-for-anktiva-plus-bcg-in-bcg-unresponsive-nmibc-with-papillary-disease-following-agency-review-of-additional-data/

3. Prodeon Medical receives FDA 510(k) clearance for the Urocross® Expander System, a novel non-permanent retrievable implant for treating urinary symptoms associated with benign prostatic hyperplasia. News release. Prodeon Medical. March 16, 2026. Accessed April 1, 2026. https://www.globenewswire.com/news-release/2026/03/16/3256258/0/en/Prodeon-Medical-Receives-FDA-510-k-Clearance-for-the-Urocross-Expander-System-a-Novel-Non-Permanent-Retrievable-Implant-for-Treating-Urinary-Symptoms-Associated-with-Benign-Prostat.html

4. U.S. FDA approves label update to accelerate thaw time for ADSTILADRIN® (nadofaragene firadenovec-vncg). News release. Ferring Pharmaceuticals. March 24, 2026. Accessed April 1, 2026. https://www.businesswire.com/news/home/20260324850788/en/U.S.-FDA-Approves-Label-Update-to-Accelerate-Thaw-Time-for-ADSTILADRIN-nadofaragene-firadenovec-vncg

5. Boston Scientific receives FDA clearance for the Asurys™ Fluid Management System. News release. Boston Scientific Corporation. March 30, 2026. Accessed April 1, 2026. https://www.multivu.com/boston-scientific/9282251-en-boston-scientific-fda-clearance-asurys-fluid-management-system

6. New FDA-cleared at-home treatment helps men regain bladder control after prostate surgery. News release. Elidah. March 31, 2026. Accessed April 1, 2026. https://elitone.com/wp-content/uploads/2026/03/Elitone-for-Men-Press-Release-033126.pdf