FDA warns Images Unlimited about multiple violations in its production and distribution of drugs and dietary supplements.
FDA releases its latest batch of Warning Letters that includes Fusion Health and Vitality and Images Unlimited Products.
FDA warns Fusion Health and Vitality that it sold unapproved, misbranded drug products intended to treat Covid-19.
FDA updates its Purple Book: Database of FDA-Licensed Biological Products to add all FDA-licensed, biological products regulated by CDER.
FDA commissioner Stephen Hahn says his agency is working with the CDC on a science-driven process to restart on-site surveillance inspections when app...
FDA commissioner Stephen Hahn, CDC director Robert Redfield and NIH National Institute of Allergy and Infectious Diseases director Anthony Fauci quara...
ICU Medical Recalls Lactated Ringers Injection
FDA grants Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu for treating patients with HER2 positive unresectable or meta...