Three stakeholders express support for FDAs LEADER 3D rare disease educational materials and suggest ways to improve them.
Amgen reports positive topline results from a Phase 3 trial evaluating a subcutaneous version of its thyroid eye disease drug Tepezza (teprotumumab-tr...
ImmunityBio says it has responded to FDAs recent Warning Letter on the companys alleged misleading promotional claims about its cancer therapy Anktiva...
FDA clears an Anumana 510(k) for an artificial intelligencebased tool designed to detect early signs of pulmonary hypertension.
FDA posts a Form 483 that identifies deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring GmbH in Marburg, Ge...
FDAs new draft guidance outlining expectations for how drug manufacturers should respond to Form FDA 483 observations following inspections of current...
FDAs just-released proposed fiscal year 2027 budget seeks a 3.3% increase or about $200 million to fund the agencys operations.
FDAs updated guidance on how patient preference information can be incorporated into regulatory decision-making for medical devices and biologics appe...
