FDA publishes 32 new and revised product-specific guidances to aid in development of generic drugs and a revised list of PSGs under development.
FDA grants Karius a breakthrough device designation for its Karius Test for use in the diagnosis and management of immunocompromised patients with sus...
The Humane Society of the U.S. petitions FDA to take actions to inform drug developers and sponsors that they are not always required to perform anima...
The Alliance for a Stronger FDA urges Congress to provide FDA with $3.9 billion in budget authority for fiscal year 2025, which is more than $200 mill...
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.
