James Hitchin
James Hitchin/LinkedIn

James Hitchin: Inside the 2025 FDA Drug Approvals

James Hitchin, VP of Alliance Management at BioAscent, shared a post on LinkedIn:

“The FDA’s Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025. This represents a decrease on 2024, which afforded the approval of 50 novel drugs, and reduces the rolling 5-year average to 48 new drugs per year.

I have compiled my usual summary of the drugs approved in 2025, together with some of their calculated properties. These values were calculated using SwissADME from the SIB Swiss Institute of Bioinformatics and ChemSpider (via the ACD/Labs Percepta Platform) from the Royal Society of Chemistry.

I hope this is useful for those who (like me) prefer to consider structures and the different structural features and properties of new drugs as part of their ongoing passion for small molecule drug discovery.

The FDA’s full list can be found here.

Please note that Narsoplimab was approved on the 24th December and has not yet been added to the FDA’s full list.”

Read more about FDA Approvals on OncoDaily.