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FDA Alerts

FDA Alert
FDA Alert
FDA Alert
HHS, FDA Initiate Removal of Black Box Warning on Hormone Therapy Products for Menopause
11/26/2025
Kate Young
On November 10, the U.S. Department of Health and Human Services announced that the FDA is initiating the removal of certain black box warnings from hormone replacement therapy products for menopause,...
11/26/2025
FDA Alert
FDA Alert
FDA Alert
FDA Approves Mitomycin Intravesical Solution for Recurrent Non-Muscle Invasive Bladder Cancer
06/20/2025
Miranda Manier, BA
The FDA has approved mitomycin intravesical solution for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
06/20/2025
FDA Alert
man on examining room with doctor holding pill bottle
FDA Alert
FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer
06/04/2025
Kate Young
The FDA announced the approval of darolutamide for treating metastatic castration-sensitive prostate cancer. This review was conducted under Project Orbis, which allows for concurrent submission and review...
06/04/2025
Bladder Cancer
Bladder Cancer
FDA Approves First Gene Therapy to Treat High-Risk Form of Bladder Cancer
01/04/2023
The FDA’s approval of the first gene therapy to treat high-risk non-muscle-invasive bladder cancer follow a multicenter clinical trial.
01/04/2023
Urology
Urology
FDA Approves New Option for Complicated UTIs
11/15/2019
The new antibacterial drug was approved after it was proven safe and effective in a study of 448 patients with complicated UTIs.
11/15/2019
Urology
Urology
Urothelial Carcinoma Drug Receives FDA Approval
05/18/2017
The FDA has approved a new option for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
05/18/2017
Urology
Urology
FDA Approves New Option for Urothelial Carcinoma
05/09/2017
The FDA has approved a drug for the treatment of patients with with locally advanced or metastatic urothelial carcinoma.
05/09/2017
Urology
Urology
FDA Approves New Treatment for Urothelial Carcinoma
05/01/2017
The FDA granted accelerated approval for a new treatment for patients with locally advanced or metastatic urothelial carcinoma.
05/01/2017
Urology
Urology
FDA Approves New Option for Urothelial Carcinoma
02/03/2017
The FDA has expanded the use of Opdivo (nivolumab) for the treatment of patients with urothelial carcinoma, the most common form of bladder cancer.
02/03/2017