US Approvals Of Novel Drugs Set To Hit 10-Year High In 2025

But 2024 will see a lull between two strong years.  

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Next year, the US Food and Drug Administration (FDA) is forecast to approve the highest number of novel drugs for at least ten years, a new analysis of Evaluate Pharma data shows. The forecast 2025 total of 74 is higher even than last year’s total of 73, itself the highest since at least 2016. (Also see "Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely" - Pink Sheet, 18 July, 2024.)

Key Takeaways
  • 2025 will see 74 new medicines approved in the US, with combined 2030 sales of $26.3bn, according to Evaluate Pharma forecast data.

They are not, however, expected to be as lucrative. A look at the forecast sales for the drugs expected to...

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