The Top Line Drug approvals went from crawl to sprint in 2025
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Jan 16, 2026 Kevin Dunleavy and Eric Saganowski, experts from Fierce Pharma, dive into the whirlwind of 2025 FDA drug approvals. They analyze the surprising surge in approvals despite agency turmoil and layoffs. The duo reveals that European firms outperformed US companies, and 57% of new drugs were for rare diseases. Insightful discussions cover the declining trend in blockbuster drugs and the implications of fewer advisory committee meetings. With a focus on oncology and the complexities of drug development, this conversation sheds light on the future of biopharma.
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Approval Count Hid A Midyear Recovery
- The FDA approved 46 novel drugs in 2025, a slight decline from prior years but within normal cyclical variation.
- Approvals nearly doubled in the second half, signaling recovery after early-year disruptions.
Layoffs Correlated With Midyear Backlog
- Massive HHS and FDA workforce cuts in early 2025 created a review backlog and drove higher rejection and delay rates midyear.
- Data showed more complete response letters and an 11% review delay rate in Q3 versus a 4% average prior.
Europe Took The 2025 Approval Lead
- European pharma firms outpaced U.S. peers in 2025, with several European companies earning multiple new approvals while no U.S. firm had more than one.
- Big European firms like Novartis and GSK each secured three approvals across diverse indications.