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.
Terumo Medical recalls its Solopath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to the potential for the tip t...
Epizyme submits an NDA seeking accelerated approval of tazemetostat for treating patients with metastatic or locally advanced epithelioid sarcoma not ...