Federal Register notice: FDA makes available a draft guidance discussing enhanced drug distribution security at the package level.
FDA acting commissioner Janet Woodcock prepares to testify 6/10 before the Senate Subcommittee on Agriculture, Rural Development, Food and Drug Admini...
FDA clears an Edwards Lifesciences 510(k) for its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff.
FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in overweight adults with obesit...
FDA approves a Chimerix NDA for Tembexa (brincidofovir) for treating smallpox.
FDA issues a clinical hold on a Ortho Regenerative Technologies Phase 1-2 clinical trial for Ortho-R, a drug/biologic combination product candidate us...
FDA releases two final and two draft guidances to help stakeholders implement provisions of the Drug Supply Chain Security Act.
Former FDA principal deputy commissioner Amy Abernethy joins Alphabets Verily as president of its clinical research business, where she will focus on ...