FDA approves a Glaukos Corp. PMA for the iStent inject Trabecular Micro-Bypass System, indicated for reducing intraocular pressure in adult mild-to-mo...
FDA accepts an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab (Rituxan) as a new treatment option for Waldenstrm's ma...
FDA clears a Zetta Medical Technologies 510(k) for its Zoom software, an MRI software algorithm for image quality enhancement and image optimization o...
Federal Register notice: FDA announces a 7/12 Antimicrobial Drugs Advisory Committee meeting to review a GlaxoSmithKline NDA.
FDA Review posts the Federal Register notices for the week ending 6/22/18.
Federal Register notice: FDA makes available a draft guidance for industry entitled Major Depressive Disorder: Developing Drugs for Treatment.
A Trump Administration government reorganization proposal aims to rename FDA the Federal Drug Administration and remove and reassign all food-related ...
FDA accepts for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for treating first-line advanc...