FDA grants priority review to Pfizer and Astellas’ sNDA for XTANDI
The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review. The sNDA is being reviewed under two initiatives
GSK has received the US Food and Drug Administration's (FDA) acceptance for its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) along with standard-of-care chemotherapy (carboplatin and paclitaxel).