Tag Archives: drug

FDA uncovers data manipulation at Immunomedics plant making cancer drug

Immunomedics received an FDA complete response letter last month tied to manufacturing concerns about its breast cancer antibody-drug conjugate. When pressed by analysts, company executives dodged questions of whether it stemmed from a preapproval inspection of its plant last year. Now the FDA has released the Form 483 from the inspection showing big issues with data… Read More »