Former FDA commissioners Scott Gottlieb and Mark McClellan call on Congress to promptly pass the VALID Act to modernize FDA regulation of laboratory-d...
FDA posts a final guidance on pharmacokinetic-based criteria used to supporting alternative dosing programmed cell death receptor-1 or programmed cell...
Federal Register notice: FDA makes available a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-A...
Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issues associated with t...
FDA updates a January safety communication about the use of Endologix AFX endovascular grafts for treating patients with abdominal aortic aneurysms.
FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was placed 11/4 on VERVE-101...
FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approved in 2017.
Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as the th...
