CBER says it plans to issue 14 guidances in three categories in the current calendar year.
FDA approves Galdermas Restylan Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21.
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...