FDA approves a Regeneron Pharmaceuticals BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol lowering therapi...
CDERs sixth annual drug safety report updates the Centers typical safety activities as well as those focused on the Covid-19 pandemic.
FDA clears an Acuitive Technologies 510(k) for its Citrefix Knotless Suture Anchor System with Citregen material technology, a bioresorbable synthetic...
Federal Register notice: FDA announces a 2/26 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Janssen Biotech emergen...
Eye on FDA reports that the CDER Office of Prescription Drug Promotion continued its anemic enforcement level in 2020.
FDA issues Eli Lilly an emergency use authorization for bamlanivimab and etesevimab administered together for treating mild to moderate Covid-19 in ad...
Fresenius Kabi Oncology pleads guilty and agrees to pay $50 million in fines and forfeitures for removing records showing violative activities from an...
FDA classifies as Class 1 a recall of Smiths Medical Medfusion Syringe Pumps (Models 3500 and 4500) due to the risk of medication delivery errors rela...