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.
October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms
Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
