Gaithersburg, MD-based Novavax says its recombinant nanoparticle protein-based Covid-19 vaccine demonstrated 100% protection against moderate and seve...
Former FDA commissioner Stephen Hahn joins Flagship Pioneering as chief medical officer of its preemptive medicine and health security initiative.
FDA sends Avenue Therapeutics a second complete response letter on its NDA for an intravenous formulation of tramadol, indicated for treating patients...
FDA Review posts the Federal Register notices for the week ending 6/11/2021.
Federal Register notice: FDA makes available a final guidance on recommendations for sponsors of medically important animal antimicrobial drugs to vol...
Federal Register notice: FDA sends to OMB an information collection entitled Study of Disclosures to Healthcare Providers Regarding Data That Do Not S...
Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment Registration and Product Listing for Manufacturer...