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 The leading web portal for pharmacy resources, news, education and careers February 23, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 23, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 35     Next >>     Go To Page:

2/23/17 - Finch Therapeutics Announces Strategic Collaboration with OpenBiome to Develop Microbiome Therapies for FDA Approval
Finch Therapeutics, Inc., a microbiome therapeutics company, and OpenBiome, a leading public stool bank, today announced a collaboration to develop FIN-403, an orally administered microbial therapy for approval by U.S. Food and Drug Administration in recurrent C. difficile infections. OpenBiome has transformed the standard of care for C. diffici
2/23/17 - IDC Receives FDA Approval for Innovative DR Imaging Devices
Calgary, Alberta- Imaging Dynamics Company Ltd. is pleased to announce that it received notification today that the United States Food and Drug Administration has granted Market Clearance approval for its new Digital Radiography product line- Aquarius 8600 1717 TC and Aquarius 8600 1417 TC. These products utilize and integrate into IDC s proprie
2/23/17 - Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataz New Animal Drug Application
By a News Reporter-Staff News Editor at Politics& Government Week- Kindred Biosciences, Inc., a biopharmaceutical company focused on saving and improving the lives of pets, announced it has received a technical section complete letter for effectiveness from the U.S. Richard Chin, CEO of KindredBio, stated, "This is a major milestone for KindredBi
2/23/17 - Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC
Novartis today announced that the US Food and Drug Administration accepted the Company's supplemental New Drug Application for filing, and granted Priority Review for the expanded use of Zykadia as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase- positive as detected by
2/23/17 - NOVOCURE LTD - 10-K - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We initially received U.S. Food and Drug Administration approval for Optune in 2011 for use as a monotherapy treatment for adult patients with GBM following confirmed recurrence after chemotherapy. In November 2014, our phase 3 pivotal trial of Optune in combination with chemotherapy for patients with newly diagnosed GBM met its endpoints after a..
2/23/17 - U.S. FDA Approves Increase in Number of Clinical Sites for E-QURE's Pivotal Trial of BST Device for the Treatment of Chronic Wound Care
E-QURE Corp., a leader in medical devices for the treatment of advanced wound care, announced today that it has received approval from the U.S. Food and Drug Administration to conduct its pivotal trial for the Company's patented Bio-electrical Signal Therapy Device in the treatment of chronic wound care as a staged study, potentially shortening the
2/22/17 - Angioplasty Balloons (Normal Balloons, Drug Eluting Balloons, Cutting Balloons, Scoring Balloons) Market Report 2017: Analysis & Forecasts 2013-2024 - Research and Markets
Research and Markets has announced the addition of the "Angioplasty Balloons Market Analysis By Type, By Application, By End Use, By Region, And Segment Forecasts, 2013- 2024" report to their offering. For instance, in December 2014 Medtronic plc received a U.S. FDA approval for their drug coated balloon IN. Normal balloon segment dominated the mar
2/22/17 - Botulinum Toxin Market Analysis - By Type, End Use & Region - Rising Demand for Minimally Invasive or Non-invasive Procedures
Dublin- Research and Markets has announced the addition of the "Botulinum Toxin Market Analysis By Type, By End Use, By Region, And Segment Forecasts, 2013- 2025" report to their offering. The global botulinum toxin market is expected to reach a value of USD 7.3 billion by 2025. For instance, Botox by Allergan received the U.S. FDA approval for the
2/22/17 - Botulinum Toxin Market Analysis - By Type, End Use & Region - Rising Demand for Minimally Invasive or Non-invasive Procedures - Research and Markets
Research and Markets has announced the addition of the "Botulinum Toxin Market Analysis By Type, By End Use, By Region, And Segment Forecasts, 2013- 2025" report to their offering. The global botulinum toxin market is expected to reach a value of USD 7.3 billion by 2025. For instance, Botox by Allergan received the U.S. FDA approval for the treatme
2/22/17 - Global Patient Monitoring Equipment Market 2017-2021
Patient Monitoring Equipment Patient monitoring equipment with specialized versions are used to monitor physiological signs. In October 2014, the company received the FDA approval for its mobile application Dexcom SHARE, which is used in Dexcom G4 PLATINUM CGM system. Technavio's analysts forecast the global patient monitoring equipment market to
2/22/17 - IDC Receives FDA Approval for Innovative DR Imaging Devices
CALGARY, AB/ ACCESSWIRE/ February 22, 2017/ Imaging Dynamics Company Ltd. is pleased to announce that it received notification today that the United States Food and Drug Administration has granted Market Clearance approval for its new Digital Radiography product line- Aquarius 8600 1717 TC and Aquarius 8600 1417 TC. These products utilize and integ
2/22/17 - Revolutionary Diagnostic SeptiCyte? LAB Cleared By FDA for Suspected Sepsis Patients
Immunexpress, Inc., a molecular diagnostic company committed to improving outcomes for suspected sepsis patients and healthcare providers, today announced it has received 510 clearance from the U.S. Food and Drug Administration for the use of SeptiCyte? LAB as an aid in differentiating infection-positive from infection-negative systemic inflamm
2/22/17 - Teleflex (TFX) Announces 510(k) Clearance and US Launch of TrapLiner? Catheter
Teleflex Incorporated, a leading global provider of medical technologies for critical care and surgery, has announced 510 clearance by the Food and Drug Administration and US commercial launch of the TrapLiner Catheter. The TrapLiner Catheter was developed by Vascular Solutions, Inc., which was acquired by Teleflex on February 17, 2017.
2/21/17 - E-QURE CORP. (OTCMKTS:EQUR) Files An 8-K Other Events
E-QURE CORP. (OTCMKTS:EQUR) Files An 8-K Other EventsItem 8.01 Other Events On November 11, 2016, E-Qure Corp., a Delaware corporation (the "Registrant"), reported on Form 8-K that on October 14, 2016, the Registrant received notification from FDA that it had been granted conditional approval to the IDE application, authorizing the Registrant to co
2/21/17 - E-QURE CORP. FILES (8-K) Disclosing Other Events
On November 11, 2016, E-Qure Corp., a Delaware corporation, reported on Form 8- K that on October 14, 2016, the Registrant received notification from FDA that it had been granted conditional approval to the IDE application, authorizing the Registrant to commence a clinical investigation of our BST Device with 10 patients at a single site. On Februa
2/20/17 - Bristol-Myers Squibb Receives FDA Approval for Opdivo nivolumab in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of...
Bristol-Myers Squibb Receives FDA Approval for Opdivo nivolumab in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer. By a News Reporter-Staff News Editor at Biotech Business Week Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration has approved Opdivo injection, for intraveno
2/20/17 - CureDuchenne Applauds the FDA Approval of Marathon's EMFLAZA deflazacort for the Treatment of Duchenne Muscular Dystrophy
By a News Reporter-Staff News Editor at Clinical Trials Week CureDuchenne applauds the U.S. Food and Drug Administration approval of EMFLAZA?, developed by Marathon Pharmaceuticals, the first drug in the U.S. approved for use by patients five and older with Duchenne muscular dystrophy regardless of genetic mutation. "For the first time all tho
2/20/17 - FDA Approves Amgen's Parsabiv Etelcalcetide, First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On...
By a News Reporter-Staff News Editor at Clinical Trials Week- Amgen announced that the U.S. Food and Drug Administration has approved Parsabiv? for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. "We are excited about today's approval of Parsabiv in the U.S. and the opportunity to p
2/20/17 - FDA Approves Bio Products Laboratory's Gammaplex 10% for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura
By a News Reporter-Staff News Editor at Clinical Trials Week Bio Products Laboratory Limited, a leading manufacturer of plasma-derived protein therapies, announced that the U.S. Food and Drug Administration has approved Gammaplex 10% for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura in adults.
2/20/17 - First automated ANCA IFA assays cleared by FDA
By a News Reporter-Staff News Editor at Pharma Business Week- Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced that the United States Food and Drug Administration has granted 510 clearance of NOVA Lite DAPI ANCA and NOVA Lite DAPI ANCA Kits for use with NOVA View ,
2/20/17 - Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataz New Animal Drug Application
By a News Reporter-Staff News Editor at Veterinary Week- Kindred Biosciences, Inc., a biopharmaceutical company focused on saving and improving the lives of pets, announced it has received a technical section complete letter for effectiveness from the U.S. Richard Chin, CEO of KindredBio, stated, "This is a major milestone for KindredBio, and it
2/20/17 - Lantheus Medical Imaging Announces FDA Approval of DEFINITY Label Update
By a News Reporter-Staff News Editor at Pharma Business Week Lantheus Medical Imaging, Inc. announced U.S. Food and Drug Administration approval of an important label update for DEFINITY Vial for Injectable Suspension which removes the contraindication statement related to use in patients with a known or suspected cardiac shunt from the U.S...
2/17/17 - Amneal Introduces Alosetron Hydrochloride Tablets, New Generic for Lotronex
By a News Reporter-Staff News Editor at Drug Week- Amneal Pharmaceuticals LLC has launched alosetron hydrochloride tablets, an AB-rated generic equivalent to Lotronex , in 0.5 mg and 1 mg strengths. The Amneal product is one of only two FDA- approved generic-equivalents for Lotronex currently available. Amneal's generic received FDA approval
2/17/17 - FDA approves deflazacort for Duchenne muscular dystrophy but manufacturer delays launch over price concerns [Sudan Tribune]
The first corticosteroid to be made available in the United States to treat Duchenne muscular dystrophy is being priced at US $89,000 a year compared with US $1,000 a year outside the United States, say congressmen. The US Food and Drug Administration has approved the first corticosteroid to be made available in the United States for the treatment
2/17/17 - FDA Approves Expanded Indication for Medtronic Freezor Xtra Cryoablation Catheter
Release date- 16022017- DUBLIN- Medtronic plc today announced the U.S. Food and Drug Administration has approved its Freezor Xtra Cryoablation Catheter for treating patients with atrioventricular nodal re-entrant tachycardia, a life-threatening abnormal heart rhythm. 'Medtronic is pleased with the FDA's decision to approve the expanded use of the..
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