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2024 in Review: FDA Approval of New Medicines

March 15, 2025
Written by Michael S. Kinch, PhD, Zachary Kraft, Tyler Schwartz

Highlights

  • The number of FDA approvals in 2024 was consistent with the five-year running average.
  • Approvals utilizing the incentives of the Orphan Drug Act reached a new high; continuing a long-term trend.
  • The rate of industry consolidation was the lowest in two decades, disrupting past tendencies.

Section Snippets

Declaration of Competing Interest

Drug Discovery TodayThe authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Michael S Kinch is Chief Innovation Officer Stony Brook University (SBU), where he researches the sources of innovation in pharmaceutical research. Prior to SBU, Dr Kinch was Executive Dean of Sciences at Long Island University, an Associate Vice Chancellor at Washington University in St Louis, led drug discovery at Yale University and was a professor at Purdue University. He previously led oncology and pandemic research activities at MedImmune and Functional Genetics....

Read more in the full version of this article

References (3)

  • K.R. Patel

    Orphan drug debate: A cheat sheet

    Manag. Care

    (2017)
There are more references available in the full text version of this article.