FDA plans a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the safety of drugs and bio...
Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.
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FDAs new draft guidance outlining expectations for how drug manufacturers should respond to Form FDA 483 observations following inspections of current...
