FDA grants Xtandi priority review for Nonmetastatic CRPC
If approved, the sNDA would expand the indication of XTANDI to include men with non-metastatic Castration-Resistant Prostate Cancer (CRPC), based on data from the Phase 3 PROSPER trial.
Bristol Myers Squibb (BMS) has reported full-year 2025 revenues of $48.2bn, essentially flat compared with $48.3bn in 2024.
HTX-011, which is a combination of local anesthetic bupivacaine and anti-inflammatory meloxicam, had produced statistically significant reductions in both pain intensity and need for opioids through 72 hours post-surgery.
The study showed that ALXN1210 achieved non-inferiority to Soliris (eculizumab) in complement inhibitor treatment-naïve patients with PNH based on the co-primary endpoints of transfusion avoidance and normalization of