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.
Ionis Pharmaceuticals has entered a licence agreement granting global pharmaceutical company Recordati exclusive rights to develop and commercialise zilganersen to treat Alexander disease (AxD) in countries outside the US.
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