FDA’s docket holds 16 more PDUFA dates by year-end

FDA is due to issue decisions on at least 16 products in December, including eight that could be categorized as new molecular entities (NMEs), as well as a new BLA that CBER is reviewing for a nerve allograft.

Approval of all eight would put the 2025 NME total at a respectable 47, down slightly from 50 last year. Products with early 2026 PDUFA dates could also get decisions by year-end, including those reviewed under the new Commissioner’s National Priority Voucher system...