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Articles: Drug/Product Approvals |
Prior Articles
Shire Targets Fourth Quarter Filing of BLA for REPLAGAL? for Fabry Disease with U.S. FDA
Shire, 10/22/09
FDA Approves New Test to Aid in the Diagnosis of Rheumatoid Arthritis
Abbott, 10/21/09 CEL-SCI To Commence First Clinical Study With Hospitalized H1N1 Infected Patients
CEL-SCI, 10/21/09 FDA approves Twynsta a new single pill combination that delivers powerful and consistent blood pressure reductions throughout 24 hours
Boehringer Ingelheim, 10/20/09
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Angiotech Pharmaceuticals Provides Update on Bio-Seal™ 510(K) Submission
Angiotech Pharmaceuticals, 10/20/09
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FDA approves Micardis as the first treatment in its class to reduce the risk of heart attack, stroke, or death from cardiovascular causes in patients at high cardiovascular risk who are unable to take ACE inhibitors
Boehringer Ingelheim, 10/20/09
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Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD
Novartis, 10/20/09
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Amgen Provides Update on Status of Prolia Biologics License Application Submitted to the U.S. Food and Drug Administration
Amgen, 10/20/09
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FDA Approves GARDASIL for Use in Boys and Young Men
Merck & Co., 10/19/09
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Dexlansoprazole MR
Expert Opinion in Pharmacotherapy, 10/19/09 Anti-Malignancy Agent/Anti-VEGF Humanized Monoclonal Antibody, Avastin Application for Approval of Additional Indication of Breast Cancer
Chugai Pharmaceutical Co., 10/19/09
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FDA approves Cervarix, GlaxoSmithKlines cervical cancer vaccine
GlaxoSmithKline, 10/19/09
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U.S. Food and Drug Administration approves CRESTOR for use in pediatric patients with heterozygous familial hypercholesterolemia
AstraZeneca, 10/19/09
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GSKs Cervarix becomes the first cervical cancer vaccine to gain approval in Japan
GlaxoSmithKline, 10/19/09
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Science and Safety
PharmExec, 10/16/09 October 14, 2009New Data Showed Type 2 Diabetes Patients Experienced Greater Blood Sugar Reductions when Treated with ACTOplus met (pioglitazone HCl and metformin HCl) as Initial Therapy Compared to Either Component Alone
Takeda Pharmaceuticals North America, 10/16/09 Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax Sprinkle Capsules
Mylan, 10/16/09 Boehringer Ingelheim receives approval from the European Commission for Mirapexin/Sifrol prolonged-release, once daily tablet for the treatment of Parkinson`s disease
Boehringer Ingelheim, 10/15/09
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EMEA recommends authorization of swine flu vaccines
Pharmaceutical Technology, 10/14/09
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FDA Issues Proposed Rule on CGMPs for Combination Drug Products
Pharmaceutical Technology, 10/14/09
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