CDER and CBER seek input to help advance the agencys model-informed drug development program.
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently circulating variants...
FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to include preventing mp...
CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell therapy for use in ...
Federal Register notice: FDA announces a minor technical modification to an alternative option that permits quarterly manufacturer reporting of certai...
Federal Register notice: FDA makes available a final guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
Johnson & Johnson files a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis.
FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures for veterinary drugs.
