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) ...
FDA clears a SurGenTec 510(k) for its TiLink-L Sacroiliac Joint Fusion System.
FDA says that while drug shortages have declined since 2011, there still are needs to be addressed to help the agency prevent or mitigate shortages.
FDA publishes a guidance to help IND and NDA sponsors evaluate the drug-drug interaction effects of their investigational drugs on combined oral contr...
FDA accepts for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treating patients with biliary trac...
FDA approves an Avita Medical PMA supplement for use of its Recell System to treat full-thickness skin defects.
