FDA warns Phoenix Biotechnology and Avila Herbals the Oleander 4X homeopathic drug they are marketing to address serious conditions such as Covid-19 i...
Two Mintz attorneys review FDA medical device regulation and policy in 2020.
Parenteral Technologies asks FDA to amend the dosing schedule for single-ingredient acetaminophen for use in children ages 2-4.
Penumbra recalls all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology due to a risk of unexpected death or serious ...
FDA cautions consumers not to use some male enhancement and weight loss products sold through Amazon and eBay.
Federal Register notice: FDA posts a final guidance on interacting with the agency about drug complex innovative trial designs.
FDA approves MicroGenics Margenza for some HER2-positive metastatic breast cancers.
FDA accepts for priority review a Takeda Pharmaceutical NDA for Eohilia (budesonide oral suspension) for treating eosinophilic esophagitis.