FDA reviewers recommend that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the XBB-lineage variant...
Federal Register notice: FDA sends to OMB an information collection extension entitled Adverse Event Program for Medical Devices.
Federal Register notice: FDA sends to OMB an information collection revision entitled Premarket Notification of Devices.
FDA posts a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests...
FDA approves an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) Linzess (linaclotide) to treat functional constipation in pediatri...
Former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis say FDA needs new policies geared toward integrating artificial int...
FDA alerts health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of...
An FDA advisory committee votes 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogens Leqembi (lecanemab) ...
