Innovation metrics like first-in-class and breakthrough therapy approvals declined as a share of novel agents in 2023, even as the US FDA’s drugs center posted one of its biggest novel approval totals ever.

Shared REMS, diverse confirmatory trials and manufacturing delays are among the highlights in the latest US FDA drug approval news from the Pink Sheet’s US FDA Performance Tracker.

The Dutch biotech says it has made good progress globally in identifying the patients who could benefit from Joenja, its recently approved treatment for activated phosphoinositide 3-kinase delta syndrome.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker