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...
CBER updates its list of guidance documents it plans to issue in 2020, noting that 16 of the 28 earlier proposed documents have already been released.
Public Citizen asks FDA for a Boxed Warning and other labeling changes for several drugs approved for Type 2 diabetes to indicate they should not be p...
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.