[ Price : $8.95]
Federal Register notice: FDA provides notice that a patent infringement lawsuit has been filed against Amgen over its BLA submissi...[ Price : $8.95]
Federal Register notice: FDA makes available final guidance entitled Clinical Considerations for Studies of Devices Intended To Tr...[ Price : $8.95]
FDA releases the form FDA-483 with three observations issued following an inspection at the Hikma outsourcing facility in Cherry H...[ Price : $8.95]
The Duke-Margolis Institute for Health Policy issues a summary with five broad themes from a meeting co-sponsored with FDA on incr...[ Price : $8.95]
Pfizer selects its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 receptor ago...[ Price : $8.95]
FDA issues Novo Nordisk a complete response letter on its BLA for once-weekly basal insulin icodec, indicated for treating diabete...[ Price : $8.95]
The Senate Appropriations Committee marks up and approves FDAs fiscal year (FY) 2025 budget, providing a $170 million (2.5%) boost...[ Price : $8.95]
FDA publishes draft guidances with recommendations on 510(k) submissions for dental composite resins and curing lights.