FDA grants Sensydia a breakthrough device designation for its Cardiac Performance System that measures critical cardiac function.
FDA extends until 2/4 a temporary postponement of certain inspection activities due to the spread of the omicron variant.
The latest FDA user fee performance report shows the agency met or exceeded many of its FY 2020 PDUFA and BsUFA goals in several different areas of fo...
Under the cloud of an HHS inspector general probe of alleged FDA coziness in the controversial approval of Biogens Alzheimers therapy Aduhelm, CDER Of...
FDA tells Revance Therapeutics that to address a recent BLA complete response letter on DaxibotulinumtoxinA for Injection will require qualification o...
FDA approves a higher-yield manufacturing process for Akari Therapeutics nomacopan for use in two Phase 3 trials.
FDA schedules a 2/10 Webinar on its draft guidance on digital health technologies for remote data acquisition.
FDA puts a partial clinical hold on multi-dose trials of Yumanity Therapeutics investigational Parkinsons disease drug.