Novel Agents Up For US FDA Approval In 2025

CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.

The FDA's 2025 user fee calendar includes a wide range of product types. (Shutterstock)

The US Food and Drug Administration started 2025 with just more than 60 novel candidates under review, according to the Pink Sheet US FDA Performance Tracker’s User Fee Goal Dates tracker.

Three novel approvals already have been granted, along with

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