FDA Novel Drug Approvals Remain Steady in 2026 First Half
FDA approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent years despite an unusually turbulent period marked by leadership turnover, high-profile regulatory disputes and policy changes under the Trump administration.
According to FDA's novel drug approvals database, the agency approved 23 new molecular entities and biologics between January and the end of June. The approvals span a broad range of therapeutic areas, including oncology, rare diseases, endocrinology and metabolic disorders.
Among the highest-profile approvals were Eli Lilly's oral GLP-1 receptor agonist orforglipron (Foundayo) for chronic weight management, Novo Nordisk's once-weekly basal insulin Awiqli (insulin icodec) for adults with Type 2 diabetes, and Denali Therapeutics’ Avlayah (tividenofusp alfa), a treatment for Hunter syndrome. FDA also approved Corcept Therapeutics’ Lifyorli (relacorilant) for platinum-resistant ovarian cancer, reflecting the continued prominence of oncology among novel approvals.
The steady approval pace contrasts with concerns earlier this year that organizational upheaval at FDA could slow reviews. Since January, the agency has undergone multiple leadership changes, including the resignation of commissioner Marty Makary, turnover among senior CDER and CBER officials, and significant staffing reductions, prompting industry concerns about review consistency and regulatory predictability.
While the number of approvals has remained historically steady, many of the year's biggest regulatory stories have involved products that were delayed, rejected or subjected to unusually contentious reviews. Several companies publicly challenged complete response letters or review decisions, while FDA also introduced new regulatory initiatives aimed at increasing flexibility for rare disease development and expanding the use of expedited review pathways.
Industry analysts have noted that the first half of 2026 demonstrates FDA reviewers have largely maintained review performance despite broader organizational disruption. At the same time, sponsors continue to cite greater uncertainty surrounding evidentiary expectations, particularly for accelerated approvals and applications relying on surrogate endpoints.
If approvals continue at the current pace, FDA would finish 2026 with roughly the same number of novel drug approvals as in recent years. The agency approved 46 novel drugs in 2025, following 50 approvals in 2024 and 55 in 2023, illustrating that overall productivity has remained historically strong even as the regulatory environment has become increasingly unpredictable.