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Keeping Track: Showers Of Approvals In US FDA’s May Forecast

 
• By Bridget Silverman

Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.

Keeping Track Feature image

A staggering 16 novel agents have user fee goal dates in the next month, carrying the potential to transform US FDA’s approval narrative for 2023.

The pending novel agents outweigh the number of other user fee goal dates coming up in May, which include four new indications, five original applications for non-novel molecules, and two biosimilars, according to the

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