Regulatory
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Found 24,958 articles
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Exelixis Initiates Rolling Submission Of U.S. New Drug Application For Cabozantinib For The Treatment Of Advanced Kidney Cancer
10/22/2015
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InSightec Submits Pre-Market Application (PMA) For FDA Approval Of Exablate Neuro For Treatment Of Essential Tremor
10/22/2015
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Transcend Medical, Inc. Submits Final Module Of FDA Premarket Approval Application For The CyPass Glaucoma Micro-Stent
10/22/2015
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Would Washington’s FDA Fix Cure Patients Or The Drug Industry?
10/21/2015
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FDA Deals a Huge Blow to Shire's Pipeline By Rejecting NDA for Dry Eye Drug
10/21/2015
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goBalto, Inc. Release: New European Clinical Trial Regulations Aim To Reduce Administrative Burden And Costs
10/21/2015
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FDA Indicates Deficiencies in Neos Therapeutics’s ADHD New Drug Application
10/20/2015
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China Biologic Products Received Operating Permit For New Branch Collection Facility In Shandong Province
10/20/2015
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Avedro, Inc. Resubmits New Drug Application To FDA For Corneal Cross-Linking
10/19/2015
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Hemispherx Biopharma Europe N.V./S.A. Receives Positive Opinion On Application For Orphan Designation By The European Medicines Agency For Alferon N Injection To Treat Patients With Middle East Respiratory Syndrome (MERS)
10/19/2015
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Tarsa Therapeutics' NDA For TBRIA, The First Oral Calcitonin For The Treatment Of Postmenopausal Osteoporosis, Accepted For Filing
10/19/2015
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Gaumard Scientific's Latest UNI Operating System Is Compliant with Newly Released 2015 AHA CPR/ECC Guidelines
10/19/2015
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FDA Seeks More Data for AstraZeneca PLC's Diabetes Combo Treatment
10/16/2015
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EDAP TMS S.A. Direct De Novo For Ablatherm HIFU Replaced By 510(K)
10/16/2015
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FDA Rejects Expanded Approval of Pfizer's Arthritis Drug Xeljanz
10/15/2015
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BioMarin Announces FDA Advisory Committee To Review Drisapersen For Treatment Of Patients With Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping
10/15/2015
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Kapa Biosystems Earns ISO 13485:2003 Certification
10/15/2015
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Alere Receives U.S. HHS Approval To Electronically Process Drug Tests For Department Of Transportation-Regulated Employees
10/15/2015
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Lannett Receives FDA Approval For Memantine Hydrochloride Oral Solution, 2 mg/mL
10/14/2015
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Redwood Scientific Technologies Announces TBX-FREE Completes FDA Registration
10/14/2015