Shots:
The US FDA has granted clearance to Hugo robotic-assisted surgery (RAS) system for use in minimally invasive urologic surgical procedures, incl. prostatectomy, nephrectomy, & cystectomy
The Hugo RAS system met its primary safety & efficacy endpoints in the Expand URO IDE study, showing performance in urologic procedures consistent with outcomes reported in published literature…
Shots:
Japan’s PMDA has accepted the NDA of nadofaragene firadenovec (intravesically; Q3W) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS ± papillary tumors (Ta/T1)
NDA was backed by P-III study evaluating nadofaragene in 157 pts, where 5yr. follow-up data showed OS rate of 80% & a 49% cystectomy-free survival in adults with CIS…

