1. Pink Sheet

Bountiful Approvals May Be Ahead As FDA Starts 2023 With Almost 60 Novel Agents Under Review

 
• By Bridget Silverman

The upcoming year could see a rebound approvals if the bigger-than-usual queue of novel agents with 2023 user fee goal dates pans out.

• Source: Shutterstock

The US FDA is starting out 2023 with one of the most well-stocked review queue in recent years, with almost 60 new molecular entities and novel biologics applications with user fee goal dates suggesting an approval in the coming year, the Pink Sheet’s US FDA Performance Tracker shows.

The count is well ahead of 2022 at the start of February, when 45 novel agents were on the upcoming user fee calendar

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