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CDER and CBER seek input to help advance the agencys model-informed drug development program.[ Price : $8.95]
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently ...[ Price : $8.95]
FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to i...[ Price : $8.95]
CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell...[ Price : $8.95]
Federal Register notice: FDA announces a minor technical modification to an alternative option that permits quarterly manufacturer...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for ...[ Price : $8.95]
Johnson & Johnson files a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis.[ Price : $8.95]
FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures fo...