Novartis says it will seek accelerated approval next year for its IgA nephropathy drug iptacopan after announcing positive top-line results from a pla...
Federal Register notice: FDA announces the opportunity for a limited number of development programs to participate in the Support for Clinical Trials ...
The U.S. government and agencies like FDA headed into the weekend as the ongoing Congressional budgetary impasse was on course to trigger a government...
FDA issues a proposed rule to reign in laboratory-developed tests and increase its scrutiny of them due to their growth in use and complexity over man...
Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Medical Devices with Physiologic Closed-Loop Contr...
Federal Register notice: FDA makes available a draft guidance entitled Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain ...
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device De Novo Requests.
Federal Register notice: FDA makes available a final guidance entitled Antimicrobial Susceptibility Test (AST) System Devices Updating Breakpoints in...
