The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The FDA has accepted the New Drug Application for ET-600, an oral solution formulation of desmopressin, for the treatment of central diabetes insipidus.

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.