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US FDA's Slim October User Fee Calendar Brings Some Controversy

 
• By Bridget Silverman

Advisory committee concerns cast clouds over Iterum’s oral antibiotic, Intercept’s Ocaliva, and perioperative immuno-oncology regimens, while CSL and Pfizer aim to take their hematology franchises in new directions.

October calendar
Fewer FDA approvals are expected in October compared to the prior month, based on the number of user fee goals. • Source: Shutterstock

October will see a slowdown in US Food and Drug Administration approval activity, with fewer than half as many user fee goal dates as September.

Key Takeaways

  • The US FDA is scheduled to decide the future of Intercept’s Ocaliva and Iterum’s oral sulopenem after negative advisory committee reviews.

  • Novel hematology agents are pending from CSL (garadacimab) and Pfizer (marstacimab)

The regulatory shoe is set to drop on two applications that endured rough advisory committee reviews, according to the Pink Sheet US FDA Performance Tracker’s User Fee Goal

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