Federal Register notice: FDA announces a 4/12 Oncologic Drugs Advisory Committee meeting to discuss the use of minimal residual disease as an endpoint...
Teleflex/Arrow International recalls the Arrow QuickFlash Radial Artery Catheterization Set (wire, guide, catheter) device due to reports about a pote...
FDA approves Italfarmacos Duvyzat (givinostat), an oral drug for treating Duchenne Muscular Dystrophy in patients six years of age and older.
Federal Register notice: FDA issues an order to permanently debar Martin Valdes from providing services in any capacity to a person that has an approv...
The Federal Trade Commission files an amicus brief calling out Teva Pharmaceuticals for improperly listed patents in FDAs Orange Book.
FDA grants Invivyd an emergency use authorization for Pemgarda (pemivibart) and its use for pre-exposure prophylaxis of Covid-19.
FDA agrees to delete its Covid-related social media posts on ivermectin as part of a settlement after three physicians who objected to the agencys mes...
An online post by attorneys from Hogan Lovells praises FDAs new draft guidance on Real-World Evidence: Considerations Regarding Non-Interventional Stu...
