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Original New Drug Application Approvals by US FDA (16-31 March 2025)

New drug applications approved by US FDA as of 16-31 March 2025 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

What’s new in advanced urothelial carcinoma?

Enfortumab vedotin and pembrolizumab’s (EV+P) EV-302 trial results represent a major advancement in metastatic urothelial carcinoma (mUC), including in Asian patients, according to Professor Ravindran Kanesvaran of the National Cancer Centre in Singapore, who also discussed managing skin toxicity associated with this regimen and provided an overview of other agents for UC under investigation at Uro-Oncology Asia 2025.

Microultrasonography a promising alternative to MRI for image-guided prostate biopsy

Microultrasonography-guided biopsy performs similarly as MRI/conventional ultrasonography fusion-guided biopsy in terms of detecting Gleason Grade Group 2 or higher prostate cancer in biopsy-naïve men, according to the results of the multicentre, international OPTIMUM study.

Skin fairness creams not fair to the kidneys

A recent review integrates multiple research findings and turns the spotlight on the growing nephrotoxic threat posed by skin-whitening creams.

How to optimize treatment strategies for mHSPC by integrating pivotal data?

Theranostics in prostate cancer management: Current strategies and real-world data

Earlier use of lutetium-177 (¹⁷⁷Lu) prostate-specific membrane antigen (PSMA)–radioligand therapy (RLT) in combination with chemotherapy is shaping the future of prostate cancer management, according to Dr Yu-Yi Huang of the Department of Nuclear Medicine, Koo-Foundation Sun Yat-Sen Cancer Center (SYSCC), Taiwan, at Uro-Oncology Asia 2025.

Tislelizumab plus nab-paclitaxel shows therapeutic potential against bladder cancer

Treatment with the combination of the immune checkpoint inhibitor tislelizumab plus low-dose nab-paclitaxel exerts promising antitumour activity in patients with very high risk non–muscle-invasive bladder cancer who are ineligible for or decline radical cystectomy, according to the results of the phase II TRUCE-02 trial.