Senate Health, Education, Labor & Pensions Committee votes 18 to 5 to advance Stephen Hahns nomination to serve as FDA commissioner to the full Senate...
Federal Register notice: FDA makes available a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.
Five bipartisan members of Congress ask HHS and CMS to include unique device identifiers on health insurance claims forms to enhance post-market surve...
FDA releases the FDA-483 with three observations from an inspection at Nubratori, Inc.
Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients with metastatic triple-...
A Ropes&Gray legal analysis says a recent Supreme Court decision could make it easier for regulated companies to argue against court granting deferenc...
The 3rd Circuit Court of Appeals asks a New Jersey federal court to look at hundreds of Fosamax bone fracture cases and determine whether they are pre...
FDA clears a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 30 days) recording, m...