FDA accepts for review a Mayne Pharma Group NDA for E4/DRSP (estetrol and drospirenone) for preventing pregnancy.
Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants because they are no longer being marketed.
FDA and the Duke-Margolis Center for Health Policy announce a 7/13-14 virtual public meeting to explore potential approaches to developing a high-qual...
FDA issues guidances to help sponsors develop drugs intended to treat three types of bacterial pneumonia.
FDA says Home Care Pharmacy of Palm Coast violated regulations involving compounded drug products and adulterated drugs.
FDA grants preCardia, Inc., a breakthrough device designation for its catheter-based system for treating volume overload in patients with acutely deco...
FDA says healthcare providers should continue to use coronavirus antibody tests to help identify people who have been exposed to the virus, while reco...
FDA lifts a partial clinical hold against an Innate Pharma Phase 2 clinical trial (TELLOMAK) that is evaluating the efficacy and safety of lacutamab i...