Latest US Food and Drug Administration Stories
The FDA plans to look into US pharmacy chain Walgreens after the company announced it will start selling genetic testing kits to help people asses their risk of inherited diseases.
MOUNTAIN VIEW, Calif., April 28 /PRNewswire/ -- Xlumena, a privately held provider of innovative technology for gastroenterologists/interventional endoscopists, today announced it has received clearance from the US Food and Drug Administration (FDA) to market its NAVIX(TM) Access Device.
Primary Endpoint achieved as required for United States Food and Drug Administration (FDA) submission BEDMINSTER, N.J.
DEARBORN, Mich., April 13 /PRNewswire/ -- SIMCO Electronics has chosen Validation & Compliance Institute (VCI) to provide online training for its employees who provide instrument calibration to the biotech, pharma and medical devices industries.
Pilot Study to Evaluate Pharmacokinetic Profile of Experimental Formulations BEDMINSTER, N.J.
WASHINGTON, March 18 /PRNewswire/ -- Ahead of World TB Day, US Food and Drug Administration Commissioner Margaret Hamburg helped public and private sector partners launch a new collaboration to significantly accelerate the development of combination treatments for tuberculosis -- and replace an almost 50-year-old drug regimen.
SAN DIEGO, March 12, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today reported financial results for the fourth quarter and full year ended December 31, 2009.
SAN DIEGO, Feb. 26, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of the lorcaserin New Drug Application (NDA).
SAN DIEGO, Feb. 24, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc.
BEDFORD, Mass., Feb. 23 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL D-Dimer HS 500 assay. Additionally, the Company received a license from Health Canada for the product.
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