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See Latest ArticlesBioMimetic Therapeutics Submits First Two PMA Modules to FDA; Company Receives ISO 9001 Certification and ISO 13485 Recertification
BioMimetic Therapeutics, 06/18/09
BioMimetic Therapeutics, Inc. announced it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009.
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FDA Approves Gardasil to Prevent Genital Warts in Males. Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
American Family Physician, 10/22/09
Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Novartis, 09/18/09
Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09
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Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09
FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)
Gen-Probe, 11/02/09
Covidien Receives FDA Approval for Oral Transmucosal Fentanyl Citrate Product
Covidien, 11/05/09
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