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pulmonary arterial hypertension
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Pluristem Therapeutics Has Been Granted a New Patent by The Australian Patent Office
Feb 20, 2014Pluristem Therapeutics, a developer of placenta-based cell therapies, has been granted a new patent by the Australian Patent Office. Patent #2007228341 covers the method and composition of matter for three-dimensional (3D) expansion of ...
Tags: 3D Cell Expansion, Pluristem
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Ikaria Would Sell The Commercial Business to Madison Dearborn Partners
Dec 30, 2013Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients, announced today that its investor group and employee shareholders ...
Tags: Ikaria, sell the Commercial Business, Madison Dearborn Partners
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United Therapeutics Obtained an Approval From FDA for Orenitram Extended-Release Tablets
Dec 24, 2013US-based biotechnology company United Therapeutics has obtained an approval from the US Food and Drug Administration (FDA) for the Orenitram (treprostinil) extended-release tablets, indicted for the treatment of pulmonary arterial ...
Tags: Extended-Release Tablets, Medicine
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Bayer HealthCare Pharmaceuticals Has Obtained FDA Approval for Its Adempas Tablets
Oct 11, 2013Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained the US Food and Drug Administration (FDA) approval for its Adempas (riociguat) tablets. Adempas tablets are developed for the treatment of adults with ...
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Bayer HealthCare Pharmaceuticals Has Obtained Two Separate Orphan Drug Designations
Sep 27, 2013Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained two separate orphan drug designations from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its investigational, oral medication ...
Tags: Drug Designations, Medicine
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FDA Cardiovascular and Advisory Committee Has Recommended Approval of Oral sGC Stimulator
Aug 9, 2013The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
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FDA Clearance for Heart Analysis System Is Seeked by Ventripoint
Feb 4, 2013VentriPoint Diagnostics has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking approval for its 2D-ultrasound system, designed for measuring right ventricle heart function in patients with pulmonary arterial ...
Tags: VentriPoint Diagnostics, FDA, pulmonary arterial hypertension
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GeNO Obtains a Clearance for Its Inhaled NO Delivery System, GeNOsyl MV-1000, From FDA
Dec 14, 2012GeNO has obtained a clearance for its inhaled nitric oxide (NO) delivery system, GeNOsyl MV-1000, from the US Food and Drug Administration (FDA). GeNOsyl MV-1000 system, which incorporates a primary delivery system, a backup system, ...
Tags: FDA, inhaled nitric oxide delivery system, clinical product, GeNO
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FDA approved Actelion Pharmaceuticals' SNDA for second generation Veletri for injection
Nov 27, 2012The US Food and Drug Administration(FDA)approved Actelion Pharmaceuticals'supplemental new drug application(sNDA)for second generation Veletri(epoprostenol)for injection. Veletri(epoprostenol)for injection is indicated for the treatment ...
Tags: FDA, Actelion sNDA, Actelion Pharmaceuticals, Veletri
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GeNo Has Received Us Patents for Its Proprietary No Generation and Delivery Technology
Nov 27, 2012GeNO has received two new US patents for its proprietary nitric oxide(NO)generation and delivery technology. The US patent no.8,173,072 describes the conversion of nitrogen dioxide(NO2)to nitric oxide(NO),using the GeNO cartridge ...
Tags: nitric oxide(NO)generation, nitric oxide(NO)delivery, US Patents, GeNO
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United Therapeutics Has Received Complete Response Letter (CRL) From The FDA
Oct 26, 2012United Therapeutics has received complete response letter (CRL) from the FDA for an oral formulation of Remodulin (treprostinil). Treprostinil is indicated for pulmonary arterial hypertension (PAH) that is at present available in ...
Tags: Medicine, Treprostinil
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Mylan Has Gained Health Canada Approval for Mylan-Bosentan Tablets
Jun 7, 2012Mylan Pharmaceuticals, the Canadian subsidiary of Mylan, has gained Health Canada approval for Mylan-Bosentan Tablets, 62.5mg and 125mg. The generic version of Actelion's Tracleer is indicated for pulmonary arterial hypertension. Mylan ...
Tags: mylan-bosentan tablet, approval, pharmaceutical product
