FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by prioritizing politic...
FDA warns Jackson, WI-based Wisconsin Pharmacal about CGMP violations in its production of finished drugs.
FDA agrees to accept a biosimilar application to compete with Johnson & Johnsons Stelara that does not include clinical efficacy studies for a monoclo...
FDA clears a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbotts Instinct continuous glucose monitoring sensor for...
HHS says FDA is removing members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Childrens Hospital of Philadelphias V...
FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work testing drugs and act...
FDA publishes the 2025 OTC drug monograph forecast showing eight items it expects to address over the next three years.
Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage...
