FDA says Baxter is recalling its Life2000 ventilators that were distributed in the U.S. between 8/2023 and 4/2024 due to potential battery charger don...
Federal Register notice: FDA provides notice that a patent infringement lawsuit has been filed against Amgen over its BLA submission for a biosimilar ...
Federal Register notice: FDA makes available final guidance entitled Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disor...
FDA releases the form FDA-483 with three observations issued following an inspection at the Hikma outsourcing facility in Cherry Hill, NJ.
The Duke-Margolis Institute for Health Policy issues a summary with five broad themes from a meeting co-sponsored with FDA on increasing clinical tria...
Pfizer selects its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 receptor agonist it is developin...
FDA issues Novo Nordisk a complete response letter on its BLA for once-weekly basal insulin icodec, indicated for treating diabetes mellitus.
The Senate Appropriations Committee marks up and approves FDAs fiscal year (FY) 2025 budget, providing a $170 million (2.5%) boost over the FY 2024 sp...
