FDA says CDER approved 55 new drugs in 2023, almost 50% more than in 2022.
FDA asks for comments on a report on agency best practices for guidance documents.
The U.S. House Energy and Commerce Committees Republican leadership opens an investigation into FDAs handling of internal scientific disagreements rel...
FDA releases the form FDA-483 issued to Indias Laurus Synthesis with five inspection observations.
FDA releases the form FDA-483 issued following an inspection at Indias Torrent Pharmaceuticals drug manufacturing facility.
Public Citizen asks FDA to revise its planned research on the misuse of drugs and other substances to ensure that no funding goes to the Researched Ab...
FDA alerts healthcare providers to not purchase or implant Synovos Total Hip System because modifications to the original device design were not clear...
Invivyd seeks FDA emergency use authorization for VYD222, which is described as a broadly neutralizing, half-life extended monoclonal antibody candida...
