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.
Two university professors question FDAs decision to assign only one reviewer to several core scientific areas in the Pfizer Covid-19 vaccine review.
An FDA advisory committee votes to recommend an Emergency Use Authorization for Modernas investigational Covid-19 vaccine (mRNA-1273).