Orphan Drug Momentum

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications.

By the end of the year, the approval picture told a more complicated story, with momentum building after a slow start.

This week on "The Top Line," we dig into what the numbers really show, which companies and therapies came out on top, and what the FDA’s performance over the course of 2025 signals for the drug review process going forward.

To learn more about the topics in this episode: 

• 2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products
• 2024 drug approvals: Small companies loom large with several key FDA nods
• 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

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