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Blood Test To Diagnose Depression
Test identifies nine blood markers tied to depression; predicts who will benefit from therapy.
Blood Cleanser for Sepsis
Dialysis-like ‘biospleen’ quickly filters bacteria, fungi and toxins.
Scientists Discover Neurochemical Imbalance in Schizophrenia
Researchers discovers that neurons from schizophrenia patients secrete higher amounts of three neurotransmitters.
Building Replacement Kidneys in the Lab
Milestone reached in work to build replacement kidneys in the lab.
Intestinal Bacteria Needed for Strong Flu Vaccine Responses in Mice
Study demonstrate a dependency on gut bacteria for strong immune responses to the seasonal flu and inactivated polio vaccines.
Stanford Engineers Aim to Connect the World with Ant-sized Radios
Costing just pennies to make, tiny radios-on-a-chip are designed to serve as controllers or sensors for the 'Internet of Things.'
Diabetes Researchers Find Faster Way to Create Insulin-producing Cells
A new protocol can turn stem cells into reliable, insulin-producing cells in about six weeks.
Genetic Testing for Prostate Cancer
Genetic testing can identify men at six-fold increased risk of prostate cancer.
Novel Method for Portable Detection of ‘Bath Salts’
Despite being outlawed in 2012 in the U.S., the synthetic drugs known as “bath salts” are still readily available in some retail shops, on the Internet and on the streets.
Mass Spectrometry in Your Hand
Electrospray arrays can dramatically downsize systems and costs for onsite chemical analysis and many other applications.
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Exploring the Global Genomic Landscape of Enteric Pathogens using DNA Microarray Technology
Dr Scott Jackson, Molecular Biologist, FDA, speaking at Advances in Microarray Technology 2012.
Date Posted: Wednesday, November 21, 2012
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FDA Issues Guidance on Use of Nanotechnology in Food Production
The three final guidances and one draft guidance provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Tuesday, July 01, 2014
FDA Proposes New Expedited Access Program for Medical Devices
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Tuesday, April 22, 2014
FDA, EMA Strengthen Pharmacovigilance Collaboration
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance topics.
Thursday, February 20, 2014
FDA Approves First Generic Versions of Antidepressant Drug Cymbalta
The U.S.FDA approved the first generic versions of Cymbalta), a prescription medicine used to treat depression and other conditions.
Monday, December 16, 2013
FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza
Vaccine to supplement National Stockpile, not intended for commercial availability.
Wednesday, November 27, 2013
FDA Takes Step to Help Ensure the Safety of Imported Food
Agency releases new proposed rules under FSMA for verifying foreign suppliers and accrediting third-party auditors.
Monday, July 29, 2013
FDA Approves Simponi to Treat Ulcerative Colitis
The U.S. FDA approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Monday, May 20, 2013
FDA Accepts Biogen Idec’s Biologics License Application
ELOCTATE™ has potential to provide long-lasting protection and markedly reduce treatment burden for patients.
Tuesday, May 14, 2013
FDA Proposes New Food Safety Standards for Foodborne Illness Prevention and Produce Safety
Public encouraged to comment on new proposals.
Monday, January 07, 2013
FDA Approves New Orphan Drug for Chronic Myelogenous Leukemia
The U.S. Food and Drug Administration has approved Bosulif (bosutinib) to treat CML, a blood and bone marrow disease that usually affects older adults.
Tuesday, September 11, 2012
FDA Approves New Treatment for a Type of Late Stage Prostate Cancer
The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer.
Tuesday, September 04, 2012
FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy
Test can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the absence of a gene mutation.
Tuesday, July 10, 2012
FDA Issues Draft Guidance on Biosimilar Product Development
The three draft guidance documents on biosimilar product development are to assist industry in developing such products in the United States.
Monday, February 13, 2012
Ikaria INOmax DS Drug Delivery System: FDA Impose Class I Recall - Erratic Nitric Oxide (NO) Readings
The erratic readings were being caused by fretting corrosion at the electrical contact interface of certain metals. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low blood pressure (hypotension), slower than normal heart rate (bradycardia), cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.
Thursday, January 05, 2012
US Tox21 to begin screening 10,000 chemicals
A high-speed robotic screening system, aimed at protecting human health by improving how chemicals are tested in the United States, has begun testing the compounds for potential toxicity.
Friday, December 09, 2011
 
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