Pfizer and BioNTech announce positive topline results from their Phase 1/2 study that is evaluating the safety, tolerability and immunogenicity of mRN...
Olympus recalls its high-flow insufflation units (model UHI-4) that are used in laparoscopic surgeries after receiving reports about patients sufferin...
Researchers from several U.S. academic medical centers suggest steps FDA and CMS could take to tighten CMS supplemental reimbursement for new medical ...
Federal Register notice: FDA releases a draft guidance entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facili...
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FDA publishes a draft guidance to assist ANDA applicants in demonstrating the bioequivalence of topical corticosteroids.
