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...
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.
Novo Nordisk agrees to pay $6.3 million to resolve allegations that it violated the False Claims Act by selling its NovoFine needles to U.S. governmen...
FDA approves Genzymes Xenpozyme to treat acid sphingomyelinase deficiency in children and adults.
Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.