FDA appointed a veteran artificial intelligence executive to lead its digital health policy unit, signaling a sharper regulatory focus on AI-driven me...
A Mintz legal update says FDA appears to be sustaining and in some cases accelerating its scrutiny of prescription drug advertising months after lau...
Olympus recalls its high-flow insufflation units, warning that continued use of the devices could cause serious injury or death.
FDA places a partial clinical hold on a MacroGenics Phase 2 (LINNET) trial of its investigational immunotherapy lorigerlimab after serious safety even...
Attorney Grant Hollingsworth outlines Trump administration changes that could positively or negatively affect a preemption defense in drug and medical...
FDA cites significant data integrity and quality control failures at an Indian manufacturing facility operated by Aurobindo Pharma that was inspected ...
FDA accepts the Sibel Aria cough sensor into its Drug Development Tool qualification program.
FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resistant breast cancer.
