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Enjoy Life® Foods CEO Tells FDA Grocery Stores Remain A Dangerous Minefield for Food Allergic, Food Intolerant and Celiac Shoppers
At the invitation of the U.S. Food and Drug Administration (FDA), Scott Mandell, CEO, President and Co-Founder of Enjoy Life Foods, the country’s lead...

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by H...

FDA Approves Treatment for Rare Neurologic Disease
The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic infl...

Oxygen Biotherapeutics Sets FDA Meeting Date for Proposed Phase IIb Oxycyte Clinical Trial
Oxygen Biotherapeutics announced that the company is tentatively scheduled to meet with the U.S. Food and Drug Administration (FDA) during the week of...

Proteon Receives FDA Fast Track Designation for First Drug Candidate PRT--201
Proteon Therapeutics announced it has received Food and Drug Administration (FDA) fast track designation for the development program for PRT-201. PRT-...

FDA Approves Testing to Explore Effectiveness of Rapid Patient Cooling in Traumatic Brain Injury Cases
Life Recovery Systems' ThermoSuit System, a rapid patient cooling device, has been approved by the U.S. Food and Drug Administration for use in a clin...

EthicAd Launches New FDA Website for Consumers
EthicAd, a nonprofit organization devoted to improving public health through consumer education, announces the launch of a new FDA Web site created to...

FDA Approves First Hepatitis B Viral Load Test
The U.S. Food & Drug Administration (FDA) has approved the Roche COBAS(R) TaqMan(R) HBV Test, the first assay for quantitating Hepatitis B Virus DNA a...

FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce neede...

St. Jude Medical Announces FDA Approval of Arecibo Manufacturing Plant
St. Jude Medical announced U.S. Food and Drug Administration (FDA) approval of the company's new facility in Arecibo, Puerto Rico, for the manufacturi...

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