FDA accepts for review an Omeros BLA resubmission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopath...
Sen. Eric Schmitt introduces legislation to create an inspector general for FDA and two other public health agencies.
FDA announces a 5/20-21 Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions.
FDA announces a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2...
FDA says it is expanding the use of unannounced inspections of foreign medical product and food manufacturing facilities.
President Trump signs an Executive Order requiring FDA to take steps to increase domestic drug manufacturing.
FDA appoints University of California, San Francisco professor Vinay Prasad to serve as CBERs new director, replacing Peter Marks, who abruptly resign...
An FDA Webinar discusses drug study information in NDAs/BLAs that will need to be electronically submitted in a certain format to assist FDA in planni...
