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.
miRecule has signed a research collaboration with EM subsidiary Rio Biofarma Brasil (RBBL) to co-develop peptide-mediated delivery technologies aimed at improving targeted ribonucleic acid (RNA) therapeutics delivery to tissues beyond the liver and muscles in a range of disease areas.
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