FDA clears an NGMedical 510(k) for its 3D-manufactured titanium cervical interbody BEE cage implant.
FDA warns American Global Health Group that it is marketing misbranded unapproved new drugs.
FDA clears NeurMedix to begin a pivotal Phase 3 clinical trial to evaluate its lead (XXX DELETE XXX) drug candidate, NE3107 in Alzheimers disease pati...
Eagle Pharmaceuticals says it is responding to an FDA complete response letter for its vasopressin ANDA.
FDA denies a Public Citizen petition asking it to rescind PMA approval for Genzymes Seprafilm but orders Warning and labeling changes for the product....
FDA lifts a clinical hold on Mustang Bios lentiviral gene therapy MB-107 and a pivotal Phase 2 clinical trial evaluating the potential Bubble Boy Dise...
Attorney Scott Lassman petitions FDA to deny a Par Sterile Products sNDA seeking to modify dosing for Vasostrict based on patient genotype.
FDA names University of Michigan associate professor Kevin Fu to a one-year term as an expert-in-residence in cybersecurity.