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Marketing Authorization
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Nestle Health Science to Invest in Therapies for Food Allergies
Nov 11, 2016Nestlé Health Science announced that it will make an equity investment of $145m in US-based Aimmune Therapeutics, which corresponds to a 15% stake after completion of the transaction. The parties also entered into a strategic ...
Tags: Food Allergies, Nestle
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Ajonomoto's Dihydrocapsiate Gains Novel Food Ingredient Status with FSA Approval
Oct 26, 2015The UK Food Standard Agency has awarded marketing authorization to Japanese food producer Ajinomoto Company for dihydrocapsiate (DHC) as a novel food ingredient to be used in powdered drinks and dietary supplements. With the ...
Tags: powdered drinks, DHC, food ingredient
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Electronic Cigarette Has Already Won The Heart of a Very Large Number of Smokers in France
Jun 9, 2014The electronic cigarette has already won the heart of a very large number of smokers in France but it also creates a huge controversy. Currently , the status of this innovative product is not yet determined. The electronic cigarette is not ...
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23andMe Seems to Have Backed off in Its Claims Enough to Appease The Agency.
Apr 8, 201423andMe, the Mountain View, CA–based consumer DNA testing company that got in hot water with FDA over its lack of PMA approval for its testing for various medically significant genes, now seems to have backed off in its claims enough ...
Tags: Health, Medicine, FDA, certification
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BMS Received Breakthrough Therapy Designation for Its Investigational DCV Dual Regimen
Feb 26, 2014Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
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GlaxoSmithKline Says It Received a Positive Opinion in Europe for Albiglutide
Feb 10, 2014LONDON, Jan. 26 (UPI) -- GlaxoSmithKline says it received a positive opinion in Europe for albiglutide, under the brand name Eperzan, for treatment of type 2 diabetes. GSK officials said the Committee for Medicinal Products for Human Use ...
Tags: Albiglutide, Glaxosmithkline, FDA
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FDA Approval for Cytoscan Dx Assay Was Obtained by Affymetrix
Jan 21, 2014Affymetrix, a manufacturer of DNA microarrays, has obtained marketing authorization from the US Food and Drug Administration (FDA) for its Affymetrix CytoScan Dx assay that can detect chromosomal variations which may be responsible for a ...
Tags: FDA Approval, Cytoscan DX Assay
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European Commission Has Granted Marketing Authorization
Dec 24, 2013The European Commission has granted marketing authorization for GlaxoSmithKline's (GSK) cervical cancer vaccine Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] as a two-dose schedule for girls aged 9 to 14. ...
Tags: cervical cancer vaccine, Medicine
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Jazz Pharmaceuticals and Gentium Have Entered Into a Definitive Agreement
Dec 23, 2013Jazz Pharmaceuticals and Gentium have entered into a definitive agreement pursuant to which a subsidiary of Jazz Pharmaceuticals will make a cash tender offer of $57.00 per share for all outstanding Gentium ordinary shares and American ...
Tags: Jazz Pharmaceuticals, Medicine
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FDA Has Approved Sovaldi 400mg Tablets
Dec 10, 2013Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
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23andMe Says It Will Stop Selling Health-Related Genetic Test Analysis
Dec 6, 2013Under pressure from the FDA, 23andMe says it will stop selling health-related genetic test analysis until it has resolved its dispute with the federal regulatory agency. "We remain firmly committed to fulfilling our long-term mission to ...
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23andMe Halted All Marketing Last Week in Accordance with The FDA's Letter.
Dec 4, 2013More than a week after the FDA told 23andMe to stop marketing its Personal Genomic Service tests, the Mountain View, CA–based company says it is complying. "23andMe halted all marketing last week in accordance with the FDA’s ...
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EMA Has Fully Validated and Granted Accelerated Assessment
Nov 28, 2013The European Medicines Agency (EMA) has fully validated and granted accelerated assessment to Boehringer Ingelheim's application for European marketing authorization of faldaprevir, a potent second generation oral protease inhibitor. ...
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FDA Is Telling 23andMe to Stop Marketing Its Personal Genomic Service Tests.
Nov 27, 2013Posted in Testing Services by Chris Newmarker on November 25, 2013 The FDA is telling 23andMe to stop marketing its Personal Genomic Service tests. The FDA’s move is but another sign that the regulator is increasingly concerned ...
Tags: 23andMe, DNA, Hit, FDA, warning letter
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Otsuka Pharmaceutical and H. Lundbeck Have Announced Marketing Authorization Approval
Nov 26, 2013Otsuka Pharmaceutical and H. Lundbeck have announced marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of ...