FDA officials say the agency is taking a whole-of-governments approach to combating the entry of illicit healthcare products into the U.S.
FDA clears a Viz.ai algorithm to give the ratio between right and left ventricle diameters in a patients heart for use in pulmonary embolism treatment...
A Florida federal judge sentenced the former CEO of Pharmatech to 37 months in federal prison after he pled guilty to several charges of lying to and ...
Ascendis Pharma files an NDA for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Allergans Ubrelvy (ubrogepant), indicated for t...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TherOxs PMA for the TherOx Downstream System, i...
FDA authorizes Modernas and Pfizer-BioNTechs updated (bivalent) Covid-19 vaccines for use as a single booster dose at least two months following prima...
A California federal judge rejects FDA regulation of a stem cell clinic, saying it is engaged in the practice of medicine.
