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October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms

 
• By Bridget Silverman

Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals

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• Source: Shutterstock

The US FDA’s user fee goal date calendar for October 2022 is slim, with only two novel agents, AstraZeneca PLC’s immuno-oncologic tremelimumab and Amicus Therapeutics, Inc.’ Pompe disease combo AT-GAA, according to the Pink Sheet’s US FDA Performance Tracker.

Of course, a quiet calendar does not guarantee calm on the FDA front, with approval decisions possible from both the history and the future of the user fee calendar: the growing list of reviews extending past user fee goal dates

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