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 »

A High-Tech Pill to End Drug Injections

Here was the challenge for bioengineers: Find a way to for patients to take drugs — like insulin or monoclonal antibodies used to treat cancers and other diseases — without injections. The medicines are made of molecules too big to be absorbed through the stomach or intestines; in any event, the drugs would be quickly… Read More »