PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today ...
The FDA has approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The intravesical mitomycin formulation is ...
PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, ...
UGN-102 achieved a 78% complete response rate at 3 months in the phase 3 ENVISION trial for recurrent low-grade NMIBC. The FDA's Oncologic Drugs Advisory Committee narrowly voted against the ...
Neoadjuvant mitomycin C showed a favorable safety profile with mild to moderate side effects, including hematuria, dysuria, and itchy scalp. The trial did not show significant improvement in 12-month ...
The PDUFA target date was set for June 13, 2025. The Food and Drug Administration (FDA) announced that it has accepted the New Drug Application (NDA) for UGN-102 for intravesical solution for the ...
Update on AVOREN trial in metastatic renal cell carcinoma (mRCC): Efficacy and safety in subgroups of patients (pts) and pharmacokinetic (PK) analysis No significant financial relationships to ...
Neoadjuvant mitomycin C prior to TURBT reduced recurrence risk by 77%, possibly by preventing free-floating cancer cells dislodged during surgery from reimplanting and by increasing local exposure at ...
Impact of dose density of adjuvant chemotherapy for locally advanced urothelial cancer. Background: Device-assisted intravesical mitomycin-C (MMC), including electromotive administration (EMDA) and ...
In recent years the management of non-muscle-invasive bladder cancer has undergone radical changes. Intravesical Bacillus Calmette-Guérin (BCG) has long been established as the therapeutic standard ...