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BioMimetic 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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Major European regulatory milestone in cardiovascular protection for Micardis : Now approved by the European Commission to reduce the risk of cardiovascular (CV) morbidity in high CV risk patients
Boehringer Ingelheim, 11/29/09

Human genome sciences submits biologics license application to fda for zalbin
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Boston Scientific Announces FDA Clearance and CE Mark for WallFlex Fully Covered Esophageal Stent
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Generic Anticonvulsant Use in Children: Do We Have Evidence to Recommend Brand Formulations?
Archives of Neurology, 11/23/09

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Therapy modifications and low-density lipoprotein cholesterol goal attainment rates associated with the initiation of generic simvastatin
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