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.

Plus deals involving Bristol Myers Squibb/Avidity, Aexon/NLS, Boehringer Ingelheim/Phenomic AI, AnaptysBio/Centessa and Biodexa/Adhera/Melior.

Armed with an old drug and new data, the group is aiming to revitalize the smoking cessation market. 

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.