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FDA rejects a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for...[ Price : $8.95]
FDA clears a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with ...[ Price : $8.95]
FDA grants a de novo marketing authorization to NOWDiagnostics for its at-home First To Know Syphilis Test.[ Price : $8.95]
Federal Register notice: FDA classifies intravenous catheter force-activated separation devices into Class 2 (special controls).[ Price : $8.95]
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify selected microbial agents th...[ Price : $8.95]
FDA issues iRhythm Technologies a Form FDA-483 after an inspection last month cited three GMP deficiencies.[ Price : $8.95]
HHS says it is working with FDA to help resolve an ongoing supply shortage of BDs Bactec blood culture media bottles.[ Price : $8.95]
AstraZeneca gains FDA approval for Imfinzi (durvalumab) with platinum-containing chemotherapy for adults with resectable non-small...