Novel Agents Up For US FDA Approval In 2025

 
• By Bridget Silverman, Nancy Pham, and Kosh Naran

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)

More from Pink Sheet Perspectives

More from Regulatory Trackers