FDA approves AstraZenecas Calquence (acalabrutinib) for use in combination with AbbVie and Genentechs Venclexta (venetoclax), a chemotherapy-free regi...
Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a head-to-head late-stage trial but failed to meet its ...
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 ...
