XTANDI (enzalutamide) capsules received FDA approval for Supplemental New Drug Application to update the U.S product labeling. The drug is sponsored by Astellas Pharma Inc. and Pfizer Inc. The SNDA is based on new data from the TERRAIN study which indicated improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were...
The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.
