FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related bone conditions.
Merck says its oral PCSK9 inhibitor met all primary and secondary endpoints in the CORALreef Lipids Phase 3 trial.
FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facility.
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...
