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FDA approves a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preven...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Devi...[ Price : $8.95]
Achaogen files an NDA for plazomicin, indicated for treating complicated urinary tract infections.[ Price : $8.95]
Amneal Pharmaceuticals says FDA should not approve any ANDA citing its Forteo as the reference-listed drug that does not contain r...[ Price : $8.95]
FDA issues a draft guidance to help sponsors develop pediatric drugs to treat GERD.[ Price : $8.95]
FDA clears a Hologic 510(k) for its Panther Fusion Paraflu assay, a multiplexed assay which runs on the new Panther Fusion system.[ Price : $8.95]
A Massachusetts federal jury says a New England Compounding Center pharmacist is guilty of racketeering and fraud, but not of seco...[ Price : $8.95]
FDA releases a video series for industry on the 2017 GDUFA reauthorizations new features.