FDA News Roundup: September 2, 2010
InfraReDx Receives FDA Clearance for LipiScan IVUS Coronary Imaging System
HSMN NewsFeed,
1 Sep 2010:
Devices, Cardiology
[InfraReDx, LipiScan, IVUS Coronary Imaging, intravascular ultrasound]
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Allergan, Inc. Receives FDA Approval for LUMIGAN(R) 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients
HSMN NewsFeed,
31 Aug 2010:
Biopharmaceuticals, Ophthalmology, FDA
[Allergan, LUMIGAN, bimatoprost, intraocular pressure, glaucoma]
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Quidel Announces FDA Clearance of Its RapidVue(R) hCG Pregnancy Lateral Flow Diagnostic Test
HSMN NewsFeed,
31 Aug 2010:
Diagnostics, FDA
[Quidel, RapidVue, hCG, human Chorionic Gonadotropin, pregnancy test]
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Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure
HSMN NewsFeed,
27 Aug 2010:
Biopharmaceuticals, Cardiology, FDA
[Novartis Pharmaceuticals, aliskiren, amlodipine, Tekamlo]
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Genentech Provides Update on FDA Application for T-DM1
HSMN NewsFeed,
27 Aug 2010:
Biopharmaceuticals, Oncology, FDA
[Genentech, Roche Group, trastuzumab-DM1, T-DM1, HER2, armed antibody]
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Medyssey Spine Receives FDA 510(k) Clearance for Zenius(TM) Thoracolumbar Spinal System in Titanium Alloy (Ti6AL-4V ELI)
HSMN NewsFeed,
25 Aug 2010:
Devices, FDA, Orthopaedic, Neurosurgery
[Medyssey, Zenius , Thoracolumbar Spinal System, spinal surgery]
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Neuralstem Files FDA Application for First Chronic Spinal Cord Injury Stem Cell Trial
HSMN NewsFeed,
25 Aug 2010:
Regenerative Medicine
[Neuralstem, stem cell, spinal cord injury, spinal cord stem cell]
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Actelion Pharmaceuticals Announces FDA Approval of Brand Name for Commercially Available VELETRI(R) (epoprostenol for injection) for Pulmonary Arterial Hypertension
HSMN NewsFeed,
25 Aug 2010:
Biopharmaceuticals, FDA
[Actelion Pharmaceuticals, VELETRI , epoprostenol, PAH]
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Celsion Receives Fast Track Designation for ThermoDox(R) Development Program to Treat Primary Liver Cancer
HSMN NewsFeed,
24 Aug 2010:
Biopharmaceuticals, Drug Delivery, Oncology, FDA
[Celsion, ThermoDox, doxorubicin, Liver Cancer]
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Radiometer's New ABL90 FLEX POC Analyzer Receives 510(k) Clearance
HSMN NewsFeed,
23 Aug 2010:
Devices, FDA
[Radiometer, ABL90 FLEX, blood gas analyzer]
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