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FDA Rethinks OTC

2014-02-21 15:40:00| Happi Breaking News

The system isn't working, says Woodcock

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FDA Accepts for Review Mercks Biologics License Application for V503, Investigational 9-valent Human Papillomavirus Vaccine

2014-02-20 14:30:00| Merck.com - Research & Development News

Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Biologics License Application for V503, its investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the U.S. Food and Drug Administration. About Merck Language: English Contact: MerckMedia Contacts:Pamela Eisele, 267-305-3558Imraan Munshi, 215-652-0059orInvestor Contacts:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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FDA rejects wider use of Xarelto drug

2014-02-15 15:47:31| Biotech - Topix.net

U.S. health regulators have again declined to approve proposed wider uses of Bayer AG and Johnson & Johnson's lucrative blood clot preventer Xarelto, the drugmakers said on Friday.

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FDA Rejects Wider Use Of J&J Xarelto For Third Time

2014-02-14 20:44:25| Food - Topix.net

Johnson & Johnson said Friday that the Food and Drug Administration has rejected - for a third time - its application to expand use of the blood thinner Xarelto to reduce dangerous blood clots and related problems in patients with coronary artery disease.

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UPDATE 2-U.S. FDA rejects wider use of Xarelto drug

2014-02-14 20:22:38| Chemicals - Topix.net

U.S. health regulators have again declined to approve proposed wider uses of Bayer AG and Johnson & Johnson's lucrative blood clot preventer Xarelto, the drugmakers said on Friday.

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