FDA 23 Novel Drug Approvals Through June 30, 2026: Best First Half Since 2023 Despite April 2025 Staff Cuts, With 79 Total Regulatory Verdicts in H1 2026 Versus 85 in H1 2025; Novel Approvals Rose From 19 in H1 2025 to 26 by Endpoints News Count
Endpoints News published a mid-year FDA review Wednesday reporting that the FDA cleared 23 novel drugs through June 30, 2026, the best first half of a year for novel approvals since 2023. The pace held up despite the Trump administration's April 2025 FDA staff cuts that industry observers had feared would slow the approval machine. Total regulatory verdicts in H1 2026 ran 79 (slight decrease from 85 in H1 2025), but novel approvals ticked up substantially from 19 in H1 2025 to 26 by the Endpoints tally (approaches vary slightly by definition; the FDA's Novel Drug Approvals for 2026 tracker shows 23 through the June 30 cutoff). Approvals during the period spanned oncology, infectious disease, nephrology, dermatology, ophthalmology, and metabolic disease. The peptide-relevant approvals within this pace include Yuviwel (navepegritide, Ascendis Pharma's once-weekly C-type natriuretic peptide prodrug for pediatric achondroplasia; accelerated approval February 27), Foundayo (orforglipron, Eli Lilly's oral small-molecule GLP-1 for chronic weight management; April 1), Tryngolza (olezarsen, Ionis's ASO for severe hypertriglyceridemia; June 24), and Trutakna (atacicept, Vera Therapeutics' BAFF/APRIL fusion protein for IgA nephropathy; July 7). The staff-cut concern has partially receded, though longer-term impacts on Center for Drug Evaluation and Research (CDER) throughput remain a Q3-Q4 2026 story to watch.