FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target S...
A Mintz legal update says FDA appears to be sustaining and in some cases accelerating its scrutiny of prescription drug advertising months after lau...
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...
FDA places a partial clinical hold on a MacroGenics Phase 2 (LINNET) trial of its investigational immunotherapy lorigerlimab after serious safety even...
Olympus recalls its high-flow insufflation units, warning that continued use of the devices could cause serious injury or death.
FDA approves AstraZenecas Calquence (acalabrutinib) for use in combination with AbbVie and Genentechs Venclexta (venetoclax), a chemotherapy-free regi...
Attorney Grant Hollingsworth outlines Trump administration changes that could positively or negatively affect a preemption defense in drug and medical...
