FDA Highlights Expedited Pathways in Drug Approval Report
FDA says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathways, underscoring the agency’s continued emphasis on speeding patient access to therapies for serious and unmet medical needs. In its just-released annual report, Advancing Health Through Innovation: New Drug Therapy Approvals 2025, CDER says it approved 46 novel drugs last year, with a substantial share benefiting from programs designed to shorten development and review timelines.
According to the report, 15 of the 46 drugs, or 33%, received a breakthrough therapy designation. That status, reserved for treatments that may offer substantial improvement over existing options, provides intensive FDA guidance and incorporates all features of the fast-track program.
Priority review was even more common. CDER designated 21 of the 46 novel drugs, or 46%, for priority review, meaning the agency aimed to complete its review within six months rather than the standard 10 months. Priority review is granted when a drug is expected to significantly improve safety or effectiveness for a serious condition. The list of priority review drugs overlapped substantially with those receiving breakthrough status, reflecting the severity of the diseases targeted.
The FDA also continued to rely on the accelerated approval pathway, which allows earlier approval based on surrogate or intermediate clinical endpoints that are reasonably likely to predict clinical benefit. Eleven novel drugs, or 24% of those approved in 2025, received accelerated approval. The agency emphasized that such approvals require post-marketing studies to confirm clinical benefit and can be withdrawn if those studies fail to demonstrate it.
Overall, CDER said 72% of novel drugs approved in 2025 used at least one expedited development or review program, including fast track, breakthrough therapy, priority review or accelerated approval. The agency characterized this as evidence of sustained momentum in bringing innovative therapies to patients more quickly.
On the operational side, the agency reported strong performance against its review timelines. Under the Prescription Drug User Fee Act, CDER met or exceeded its goal date for 96% of novel drug approvals in 2025, taking action on 44 of the 46 approvals on or before their scheduled target dates.
Additionally, CDER approved 39 of the 46 novel drugs, or 85%, on the first cycle of review, reflecting what the agency described as clearer guidance to sponsors on study design and data requirements. In addition, 32 of the 46 drugs, or 70%, were approved in the U.S. before any other country, reinforcing the U.S. role as an early launch market for new therapies.
Taken together, the FDA said the 2025 data demonstrate continued progress in regulatory efficiency and predictability, while maintaining standards for safety and effectiveness. The agency said it expects expedited programs to remain a central tool as drug developers increasingly focus on serious, rare and life-threatening diseases.