Posted by Michael Wonder on 15 Jul 2025
Regulatory and clinical outcomes of non-oncology accelerated approvals
14 July 2025 - The US FDA accelerated approval pathway expedites drug approvals based on changes to surrogate or intermediate measures only “reasonably likely” to predict clinical benefit.
Therapies granted accelerated approval must undergo confirmatory trials to evaluate their clinical benefits. Since the program’s inception, about 10% of new drugs have used the pathway, with 80% of these in oncology.
