CDER creates a new internal Artificial Intelligence Council to oversee, coordinate, and consolidate all Center AI activities.
FDA grants Nuvectis Pharma an orphan drug designation for NXP800 and its use in treating ovarian, fallopian tube, and primary peritoneal cancers.
FDA approves a Renata Medical PMA for its Minima Growth Stent thats intended for treating congenital heart disease in infants and young children.
Liveyon founder and CEO John Kosolcharoen pleads guilty to a felony charge of introducing an unapproved new stem cell product into interstate commerce...
FDA publishes a guidance describing and clarifying several aspects of the Voluntary Malfunction Summary Reporting program.
Researchers call on FDA to require postmarketing studies for breakthrough therapy-designated drugs studied with surrogate endpoints for traditional ap...
Abbott Diabetes Care begins a Class 1 recall (device correction) of its FreeStyle Libre 3 sensors based on users reporting situations where they were ...
An FDA inspection of a Global Calcium manufacturing facility in Hosur, India leads to a six-observation Form FDA-483 that cites significant GMP violat...
