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.
AstraZeneca gains FDA approval for Imfinzi (durvalumab) with platinum-containing chemotherapy for adults with resectable non-small cell lung cancer.
The Washington DC District Court rejects a Novartis motion in a generic drug carve-out case for a preliminary injunction to stay FDAs approval of MSN ...
Federal Register notice: FDA withdraws approval of Cubist Pharmaceuticals Entereg (alvimopan) capsules because it is no longer marketed.
