The FDA published over 200 response letters sent as replies to drug and biological product applications in order to increase transparency.

The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.

In a surprise post this afternoon, new FDA Commissioner Dr Martin Makary announced a completed pilot at the FDA of a generative AI-based system for speeding up drug review - and plans to roll out ...

The FDA has started a priority review of Insmed's brensocatib, which is pitching to become the first approved therapy for bronchiectasis in the US.

In a landmark move to improve transparency and modernize regulatory processes, the U.S. Food and Drug Administration (FDA) ...