CDER Office of Surveillance and Epidemiology director Gerald Dal Pan says the number of drug adverse event reports set a record in 2018 because more d...
Federal Register notice: FDA determines that AbbVies Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of sa...
FDA announces a 7/17 public workshop entitled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.
FDA approves an Astellas Pharma supplemental NDA to update the U.S. product labeling for Xospata (gilteritinib) to include final analysis data from th...
Five FDAers working in oncology say there is a need for more patient-friendly language to use in communicating oncology drug risks and benefits.
FDA clears a Medivis 510(k) for its SurgicalAR, an augmented reality technology platform for surgical applications and its clinical use in the operati...
FDA grants Resolution Bioscience a Breakthrough Device Designation for the Resolution HRD liquid biopsy assay, a qualitative in vitro diagnostic to de...
The Justice Department says Almirall is settling a whistleblower case alleging improper kickbacks to doctors for $3.5 million.