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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 Drug Approval Summary: Bevacizumab (Avastin) as Treatment of Recurrent Glioblastoma Multiforme
The Oncologist, 12/03/09
Ustekinumab (Stelara): First-in-class human monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasis
Formulary , 12/02/09
Safety concerns slow new drug review and approval processes
Formulary , 12/02/09
Today in Drug/Product Alerts...keeping you current
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Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic
Shire, 12/03/09
Allos Therapeutics Announces Issuance of U.S. Patent for FOLOTYN
Allos Therapeutics, 12/01/09
Generic Anticonvulsant Use in Children: Do We Have Evidence to Recommend Brand Formulations?
Archives of Neurology, 11/23/09
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