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 The leading web portal for pharmacy resources, news, education and careers February 27, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 27, 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 31     Next >>     Go To Page:

2/25/17 - Baebies Receives FDA de novo Clearance for First Lysosomal Storage Disease Newborn Screening Platform, SEEKER
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week- Baebies, a company focused on advancing newborn screening and pediatric testing, announced it has received de novo clearance from the U.S. Food and Drug Administration for SEEKER. "Although these LSDs have FDA approved therapies, this is a significant milestone for the LSD
2/25/17 - FDA Approves EMFLAZA? deflazacort Tablets and Oral Suspension for the Treatment of Duchenne Muscular Dystrophy in Patients 5 Years and Older
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week The FDA granted EMFLAZA priority review, which is reserved for investigational medicines that may offer major advances in treatment over existing options. "We are pleased to learn that the FDA has approved EMFLAZA," said Pat Furlong, founding President and CEO of Parent Proj
2/25/17 - Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage XR [T-break Tech (Middle East)]
Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration for the Company`s abbreviated new drug...
2/24/17 - bioMrieux's VIDASB?R?A?H?M?SPCT? Becomes the First FDA-Cleared Procalcitonin Assay as an Aid for Antibiotic Stewardship in Respiratory Infections and Sepsis
With these two new additional claims, VIDAS B? R? A? H? M? S PCT? becomes the first and only FDA- cleared procalcitonin test available in the U.S. market to assist physicians in antibiotic management for patients with suspected or confirmed LRTI or sepsis. Antimicrobial resistance is considered as a major threat to public health and
2/24/17 - FDA Clears Test To Help Manage Antibiotic Treatment For Respiratory Infections
WASHINGTON- The U.S. Food and Drug Administration Thursday cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis.
2/24/17 - Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage XR
Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration for the Company's abbreviated new drug.
2/24/17 - Intersect ENT Announces FDA Approval of Newest Steroid Releasing Implant, PROPEL Contour, for Use in Treating the Frontal and Maxillary Sinuses
Intersect ENT, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that the company has received approval from the U.S. Food and Drug Administration for its PROPEL Contour steroid releasing sinus implant. Intersect ENT's PROPEL Contour steroid releasing sinus implant. The approv
2/24/17 - INTERSECT ENT, INC. FILES (8-K) Disclosing Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01 Regulation FD Disclosure. On February 24, 2017, Intersect ENT, Inc. issued a press release announcing that the Company has received approval from the U.S. Food and Drug Administration for its PROPEL Contour steroid releasing sinus implant. Description 99.1 Press release entitled "Intersect ENT Announces FDA Approval of Newest Steroid R
2/24/17 - NetworkNewsBreaks Intellipharmaceutics International, Inc. (NASDAQ: IPCI) Shares Higher on FDA Approval of Two Strengths of Generic Glucophage XR
Intellipharmaceutics International shares were up 27% this morning following news that it has received final approval for its abbreviated new drug application for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths from the U.S. Food and Drug Administration. We are actively evaluating options to realize commercial...
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
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