Excerpt
• The forty-four approvals by FDA in 2022 fell below recent rates but is within the long-term average. • Approvals for orphan indications captured more than half of all approvals. • Industry consolidation and turnover continued at a slightly lower rate.
Kinch, MS, Schwartz T, Kraft Z. 2023. 2022 in Review: FDA Approval of New Medicines. Drug Discovery Today, https://doi.org/10.1016/j.drudis.2023.103622.
An accounting 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 44 new entities in the year 2022. Oncology-based drugs continued to be the most popular indication for these medicines. Likewise, orphan indications encompassed more than half of new drug approvals. The number of new entities approved in 2022 declined from its peak after 5 years of more than 50 annual approvals. Likewise, the rate of consolidations slowed somewhat, among both new entries in the realm of clinical-stage developers and more established organizations.