FDA issues a Warning Letter to A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising concerns about micr...
Johnson & Johnson files a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia.
FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target S...
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.
