FDA clears a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increased risk of atrial fib...
FDA clears a Fujifilm Healthcare Americas 510(k) for its new compact, 128-slice computed tomography (CT) system, the FCT iStream.
Public Citizen recommends three steps FDA should take to improve the public perception and understanding of the work of agency advisory committees.
FDA publishes a table with information on 14 drug submissions in FY 2023 that contained real-world evidence.
FDA publishes a guidance to help sponsors pursue Priority Zoonotic Animal Drug designation for a new animal drug.
FDA publishes a draft guidance on the content and format of certain diversity action plans intended to increase clinical study enrollment of participa...
FDA approves a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult p...
BrainStorm Cell Therapeutics says it has reached alignment with FDA on chemistry, manufacturing, and controls aspects of the companys upcoming Phase 3...
