FDA rejects a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for Yutrepia (treprosti...
FDA clears a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with its next-generation ...
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify nucleic acid targets in respiratory specimens fr...
FDA grants a de novo marketing authorization to NOWDiagnostics for its at-home First To Know Syphilis Test.
Federal Register notice: FDA classifies intravenous catheter force-activated separation devices into Class 2 (special controls).
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify selected microbial agents that cause acute febri...
FDA issues iRhythm Technologies a Form FDA-483 after an inspection last month cited three GMP deficiencies.
HHS says it is working with FDA to help resolve an ongoing supply shortage of BDs Bactec blood culture media bottles.
