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FDA annual antibiotics report

2015-12-28 15:15:00| National Hog Farmer

By P. Scott Shearer, Bockorny Group, Washington, D.C. The FDA released its annual antibiotics report that showed increases in both the sale and distribution of antibiotics for use in food-producing animals in 2014 read more

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Luminex's NxTAG Respiratory Pathogen Panel obtains FDA clearance

2015-12-20 18:12:23| Biotech - Topix.net

Luminex Corporation today announced that it has received FDA clearance for its NxTAG Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia . The panel is the only respiratory assay that enables laboratories to easily and simultaneously detect 20 respiratory pathogens in a single closed tube system in a format that scales to accommodate changes in throughput needed to respond to seasonal changes in demand, especially during flu season.

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Us Fda warns India's Sun Pharma for violating manufacturing standards

2015-12-19 13:30:10| Chemicals - Topix.net

India's largest drugmaker Sun Pharmaceutical Industries Ltd said it had received a warning letter from the U.S. Food and Drug Administration for violating manufacturing standards at its Halol plant in western India. An employee speaks on phone as he walks out of research and development centre of Sun Pharmaceutical Industries in Mumbai.

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FDA Approves Expanded Indication for Mercks KEYTRUDA (pembrolizumab) for the Treatment of Patients with Advanced Melanoma

2015-12-18 22:05:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KEYTRUDA is Now the First and Only Anti-PD-1 Therapy to Achieve Superior Overall Survival Compared to Ipilimumab KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. Language: English Contact: MerckMedia Contacts:Pamela Eisele, 267-305-3558orAn Phan, 908-255-6325orInvestor Contacts:Teri Loxam, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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