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Published on: August 18, 2023
2023 in review: FDA approvals of new medicines
Michael S Kinch1, Zachary Kraft1, Tyler Schwartz1
1Center for Research Innovation in Biotechnology, Long Island University, Northern Boulevard, Greenvale, NY 11548, USA.
Abstract:
An analysis of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 69 new entities in the year 2023, 50 % more than in the previous year. Oncology drugs tied with congenital and infectious diseases drugs for the most approvals. Although orphan and priority approvals continued at a high pace, the rate of fast-track approvals continued to decline. The rate of industry consolidation also picked up again after decreasing slightly in 2022.
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