Here are the 10 FDA decisions to watch for the remainder of 2025, listed chronologically by expected decision date. 10 FDA Decisions to Watch in Q4 20251. The FDA set a PDUFA date of October 13, 2025. The FDA assigned a PDUFA date of November 30, 2025, and stated it does not currently plan to convene an advisory committee meeting. The NDA was originally accepted by FDA in December 2024, with a standard review and an initial PDUFA date of September 26, 2025.