FDA posts a guidance entitled: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that describes the agencys current thinking on such ...
FDA clears a Nitiloop 510(k) for the Nova Cross Extreme and Nova Cross BTK, dedicated microcatheters for use in conjunction with conventional guidewir...
FDA approves a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preventing delayed nausea ...
Federal Register notice: FDA makes available a guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device that clarifies wh...
Achaogen files an NDA for plazomicin, indicated for treating complicated urinary tract infections.
Amneal Pharmaceuticals says FDA should not approve any ANDA citing its Forteo as the reference-listed drug that does not contain recombinant human par...
FDA issues a draft guidance to help sponsors develop pediatric drugs to treat GERD.
FDA clears a Hologic 510(k) for its Panther Fusion Paraflu assay, a multiplexed assay which runs on the new Panther Fusion system.