The Food and Drug Administration on Thursday selected nine drugs for expedited reviews intended to speed up the approval process. Why it matters: The awarding of the new priority review vouchers is a ...
Drug developers secured approvals for 46 new therapeutic agents from the FDA’s Center for Drug Evaluation and Research (CDER) in 2025. This cohort brings the 5-year average down a touch, to 48 new ...
FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.