Pfizers Hospira drug unit recalls several drug lots of 4.2% sodium bicarbonate injection, 1% lidocaine HCl injection, and 2% lidocaine HCl injection d...
FDA amends the emergency use authorization of Novavaxs Covid-19 vaccine adjuvanted, for use in individuals 12 years of age and older to include the 20...
FDA sends Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating frown lines and crows feet in certa...
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...
