FDA releases a final guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.
FDA sends Eli Lilly a complete response letter due to inspection problems impacting its BLA for lebrikizumab, indicated for treating moderate-to-sever...
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...
