CBER publishes its calendar year 2021 guidance agenda with 16 items in four categories.
FDA grants accelerated approval six weeks before the goal date for Immunomedics Trodelvy in some urothelial cancer patients.
FDA publishes a Covid-19 guidance on remote interactive evaluations of drug manufacturing and storage, bioresearch monitoring, and outsourcing facilit...
FDA acting FDA commissioner Janet Woodcock says the agencys pandemic recovery phase planning will prioritize facility surveillance and inspections.
FDA clears an expanded indication for the Avitus Bone Harvester.
FDA and CorMedix agree to a study protocol required in the agencys DefenCath complete response letter.
FDA and CDC recommend a pause in using the Johnson & Johnson (Janssen) Covid-19 vaccine due to concerns about potential blood clots.
Federal Register notice: FDA announces a 5/11-12 Oncologic Drugs Advisory Committees Pediatric Oncology Subcommittee meeting to review a patient-repor...