A randomized trial by Al-Azhar University is assessing the non-inferiority of single-tract nephrolithotomy versus multi-tract nephrolithotomy for complex renal stones, focusing on stone-free rates and various secondary outcomes.

ClinicalAugust 16, 2026

Icahn School of Medicine initiates trial for CaOx stone prevention strategies

The Icahn School of Medicine at Mount Sinai is conducting a randomized controlled trial to compare empiric therapy versus selective therapy for calcium oxalate stone prevention in 80 patients undergoing percutaneous nephrolithotomy.

RegulatoryAugust 15, 2026

Teva Pharmaceuticals receives AP status for Vardenafil Hydrochloride ANDA091347

Teva Pharmaceuticals has received Abbreviated Approval (AP) status for its ANDA091347 application for Vardenafil Hydrochloride, a treatment for erectile dysfunction.

CompetitiveAugust 9, 2026

FDA Approves Tadalafil Application ANDA210329 by Jubilant Generics

The FDA has approved the original application ANDA210329 for Tadalafil submitted by Jubilant Generics.

RegulatoryAugust 5, 2026

FDA Accepts Supplement Application for Tamsulosin Hydrochloride by Synthon BV

The FDA has accepted a supplemental application for Tamsulosin Hydrochloride submitted by Synthon BV.

RegulatoryAugust 2, 2026

FDA Approval Application for Mirabegron Submitted by Deva Holding

The FDA has received an application (ANDA219941) for Mirabegron from Deva Holding, currently under standard review.

ClinicalAugust 1, 2026

Trial of L-Citrulline and Tadalafil for Erectile Dysfunction Shows Potential Combination Benefits

A randomized trial is comparing L-citrulline, tadalafil, and their combination in men with mild to moderate erectile dysfunction.

RegulatoryAugust 1, 2026

FDA Accepts Supplement for Finasteride by Sun Pharma

The FDA has accepted a supplemental application for Finasteride (ANDA090508) submitted by Sun Pharma.

ClinicalJuly 30, 2026

Comparative Study of Water Vapor Therapy vs. Bipolar Enucleation for BPH

A study is underway to compare Water Vapor Thermal Therapy and Ejaculation-Sparing Bipolar Transurethral Enucleation in treating BPH.

ClinicalJuly 27, 2026

enGene Initiates LEGEND Study of EG-70 in BCG-Unresponsive NMIBC Patients

The LEGEND study will evaluate the safety and efficacy of EG-70 in patients with BCG-unresponsive NMIBC.

StrategyJuly 18, 2026

Jubilant Generics receives FDA approval for Tadalafil ANDA210329

Jubilant Generics has received an Abbreviated New Drug Application (ANDA) approval for Tadalafil.

ClinicalJuly 17, 2026

Venlafaxine Shows Promise in Treating Bladder Pain Syndrome with Behavioral Intervention

A study is comparing venlafaxine combined with behavioral intervention against behavioral intervention alone for bladder pain syndrome.

ClinicalJuly 16, 2026

Trial of Elidah Device for Urinary Incontinence Post-Prostate Cancer Treatment

A clinical trial is underway to evaluate the effectiveness of the Elidah device in reducing urinary incontinence in men post-prostate cancer treatment.

ClinicalJuly 15, 2026

Study Compares R.E.C.K vs Exparel for Pain Management in Robotic Nephrectomy

A study is underway to compare the efficacy of R.E.C.K and Exparel in managing postoperative pain in robotic nephrectomy.

StrategyJuly 12, 2026

FDA Grants Approval for Mirabegron ANDA219941 by Deva Holding AS

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 219941 for Mirabegron submitted by Deva Holding AS.

RegulatoryJuly 11, 2026

FDA Accepts Supplement Application for Finasteride by Sun Pharma

The FDA has accepted a supplemental application for Finasteride submitted by Sun Pharma.

ClinicalJuly 10, 2026

MT-ND1 Mutation Linked to Male Infertility in Chinese Population

The study identifies a significant association between the MT-ND1 m.3700G>A mutation and impaired sperm production in men with idiopathic non-obstructive azoospermia.

StrategyJuly 9, 2026

FDA Grants Abbreviated Approval for Finasteride ANDA090121

The FDA has granted abbreviated approval for Finasteride under application ANDA090121 submitted by Accord Healthcare.

StrategyJuly 9, 2026

Teva's Finasteride ANDA076511 Receives Abbreviated Approval from FDA

Teva's ANDA076511 for Finasteride has received an Abbreviated Approval from the FDA.

RegulatoryJuly 9, 2026

FDA Grants AP Status for Finasteride ANDA076437 by Dr. Reddy's Labs

The FDA has granted approval status (AP) for Dr. Reddy's Labs' ANDA076437 for Finasteride.

StrategyJuly 9, 2026

Aurobindo Pharma's Finasteride ANDA078341 Receives AP Status

Aurobindo Pharma's ANDA078341 for Finasteride has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJuly 9, 2026

Aurobindo Pharma submits SUPPL for Alfuzosin Hydrochloride (ANDA079060)

Aurobindo Pharma has submitted a supplemental application for Alfuzosin Hydrochloride under ANDA079060.

ClinicalJuly 1, 2026

Trial Comparing Suction Mini-PCNL to Standard PCNL for Kidney Stones Launched

A multicenter, international randomized controlled trial is underway to compare suction mini-PCNL with standard PCNL for 2-4 cm kidney stones.

ClinicalJune 29, 2026

Study on Tactile Feedback Training for Stress Urinary Incontinence in Pregnant Women

A clinical trial is evaluating the effectiveness of tactile feedback pelvic floor training compared to traditional methods for managing stress urinary incontinence in pregnant women.

RegulatoryJune 29, 2026

Defect Notification for Hiprex 1g Tablets Due to Braille Embossing Error

A Class 4 Medicines Defect Notification has been issued for Hiprex 1g tablets due to an error in Braille embossing on packaging.

ClinicalJune 29, 2026

New Device for Bladder Control in Men with SCI Shows Promise

A new device for noninvasive electrical stimulation aims to improve bladder control in men with spinal cord injury.

ClinicalJune 29, 2026

Study on Dietary Oxalate's Impact on Kidney Stone Disease and Immunity

A study is underway to assess the effects of dietary oxalate on urinary crystals and immune response in healthy individuals.

RegulatoryJune 28, 2026

Quadrant Pharmaceuticals Issues Class 4 Medicines Defect Notification for Vesomni Tablets

Quadrant Pharmaceuticals has reported Class 4 Medicines Defect due to incorrect barcode/GTIN on Vesomni tablets.

ClinicalJune 22, 2026

Trial Compares Tamsulosin Dose Escalation vs. Silodosin Switch in BPH-Related Urinary Retention

A randomized controlled trial is assessing the efficacy of tamsulosin dose escalation versus switching to silodosin in men with acute urinary retention due to BPH.

Upcoming catalysts

No catalysts indexed for this entity yet.

Indications

Bladder Cancer →

Bladder Pain Syndrome →

Kidney Stone Disease →

Newsletter

Get signals before the market moves

Concise strategic intelligence on regulatory, clinical, competitive, and market developments — free to subscribe.

No paywall. No spam. Unsubscribe anytime.