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FDA schedules a 2/10 Webinar on its draft guidance on digital health technologies for remote data acquisition.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.
FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as a...
Three Skadden Arps attorneys explore the reasons why life sciences companies may see increased enforcement activity from FDA and the Justice Departmen...
Gilead says it believes it has stopped the distribution of counterfeit HIV drugs from reaching patients.