Qiagen and Myriad Genetics announce a collaboration to develop cancer companion diagnostic tests.
CDERs Office of Prescription Drug Promotion launches a new Web page to display untitled letters issued for drug advertising and promotion violations.
Sens. Grassley and Warren urge FDA to quickly voice its support for including a device identifier on Medicare claims forms.
FDA publishes a draft guidance to assist ANDA applicants in demonstrating the bioequivalence of topical corticosteroids.
After reporting favorable study data in those aged 50-59 years, GSK says it will seek FDA approval for an expanded use of Arexvy (respiratory syncytia...
Federal Register notice: FDA sends to OMB an information collection revision entitled Standardized Reporting Forms for FDA Federally Funded Public Hea...
Three developers of the Intarcia Therapeutics ITCA 650 drug-device implantable product to improve glycemic control accuse CDER officials of making err...
FDA publishes a draft guidance describing its process for requesting and conducting voluntary remote interactive evaluations of some drug and bioresea...
