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.
FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.
FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed from any location as...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for made during January, February, and March.
FDA says CTK Biotechs ImmuView Covid-19 Antigen Home Test now has a longer shelf life than previously authorized.
