CDERs Office of Generic Drugs launches a new pilot program to offer meeting opportunities to generic drug applicants who intend to use model-integrate...
FDA Webview editor Jim Dickinson discovers high-level corruption equivalent to the 1989 Generic Drug Scandal in Jeff Shurens CDRH, in which FDA employ...
FDA approves a Novo Nordisk NDA for Rivfloza (nedosiran) injection, a once-monthly subcutaneous ribonucleic acid interference therapy for lowering uri...
Federal Register notice: FDA makes available a final guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on W...
FDA clears an Anumana 510(k) clearance for ECG-AI LEF, an artificial intelligence-powered medical device to detect low ejection fraction in patients a...
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...
