FDA commissioner Robert Califf and associate commissioner for womens health Kaveeta Vasisht tout successes of the agencys Office of Womens Health in i...
Eisai opens a rolling BLA submission for an autoinjector to deliver maintenance doses of Leqembi in patients with early Alzheimers disease.
Parenteral Technologies asks FDA to ban specific language from the directions for some liquid acetaminophen products indicated for certain infants.
FDA clears an Atraverse Medical 510(k0 for its Hotwire radiofrequency guidewire, a device that enables zero exchange left-heart access.
Abbott recalls (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood or air leakages.
Federal Register notice: FDA issues an order permanently debarring Gina Acosta from providing services in any capacity to a person that has an approve...
Federal Register notice: FDA posts a technical amendment to its animal drug regulations for labeling new animal drugs included on the agencys Index of...
FDA approves the Roche HPV self-collection solution that the company says can expand access and screening options to help eliminate cervical cancer.
