Federal Register notice: FDA announces the issuance of an emergency use authorization for Invivyds Pemgarda (pemivibart) for use as Covid-19 pre-expos...
FDA warns Chinas Ostar Beauty Sci-Tech about illegally marketing unapproved medical devices.
FDA warns Charlottesville, VA-based ION Intelligence of Nature about multiple violations in its production of drugs and dietary supplements.
FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.
Teva says FDA should drop its recommendation for the use of dedicated manufacturing facilities for ezetimibe to prevent cross-contamination.
FDA publishes for comment the International Council for Harmonization M14 guidance on general principles for planning, designing, and analyzing pharma...
FDA accepts for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with standard of care for treating patients with tr...
FDA co-sponsors a 6/26-27 public workshop on using patient-generated health data in medical device development.
