The FDA reports 27 full-approval actions and 9 tentative-approval actions through December 17, 2025 as posted on its daily (here) and all approvals (here) pages. This total of 36 full- and tentative-approval actions appears to be on the average side and, with the holiday coming up and the number of employees likely absent for vacation, it does not seem as though the OGD will be able to surpass the numbers seen in the first month of FY 2026 unless there is big push of approvals in the last days of this month.
While December is usually one of the best months for approvals (December 2025 saw 67 full and 25 tentative approvals), it looks like this year’s December figure will fall far short of last year’s December output.
