Abbott Medical recalls (Class 1) its HeartMate System Monitor due to atypical behavior of the System Monitor screen.
FDA publishes a guidance with additional details on earlier guidances on evaluating the effectiveness of drugs indicated to treat heartworm in dogs.
FDA releases the form FDA-483 with six observations from an inspection at a Goa, India, Cipla drug manufacturing facility.
FDA associate commissioner for global policy and strategy Mark Abdoo says the agency will support the African Medicines Agency through a new office in...
FDA modifies the REMS for CAR T cell products to ease the burden on hospitals and their clinics.
Federal Register notice: FDA makes available a draft guidance entitled Diversity Action Plans to Improve Enrollment of Participants from Underrepresen...
Federal Register notice: FDA makes available a final guidance entitled Priority Zoonotic Animal Drug Designation and Review Process.
FDA sends Daiichi Sankyo and Merck a complete response letter on their BLA for patritumab deruxtecan (HER3-DXd) for treating certain adult patients wi...
