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...
Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Establishing Bioequivalence.
Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing disease progression in c...
