FDA says an Applied Medical recall of three embolectomy and cleaning catheters is Class 1.
PhRMA says it generally supports the FDA capacity planning adjustment methodology for drug and biologic user fee programs.
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 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...
FDA grants Eli Lilly accelerated approval three months ahead of schedule for Retevmo (selpercatinib) for certain patients with non-small cell lung can...