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US FDA’s November Goal Dates Cannot Elevate 2024’s Novel Approvals To 2023 Levels

 
• By Bridget Silverman

Another record-breaking year for novel approvals looks out of reach, but the six novel agents with November goal dates show the continued strength of rare disease drug development.

The FDA's November calendar includes user fee goal dates for six novel agents. (Shutterstock)

With only six novel candidates on its November 2024 user fee calendar, the US Food and Drug Administration is running out of chances to reach its 2023 total of 72 new molecular entities and novel biologic approvals.

Through the end of October 2024, the FDA cleared 45 novel agents, including 38 from the Center for Drug Evaluation...

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