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 The leading web portal for pharmacy resources, news, education and careers June 22, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - June 22, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 74     Next >>     Go To Page:

6/22/18 - FDA Approves Automated Insulin Delivery and Monitoring System for Use in Younger Pediatric Patients
The U.S. Food and Drug Administration today expanded the approval of the MiniMed 670 G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes. The FDA origin
6/21/18 - AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial [Syrian Arab News Agency]
AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase II clinical trial investigating the Company`s ROOT OF CANCER technology in patients with glioblastoma multiforme. This will be the third...
6/21/18 - BAUSCH + LOMB RECEIVES FDA PRE-MARKET APPROVAL FOR ENVISTA TORIC MX60T INTRAOCULAR LENS
BRIDGEWATER- Bausch+ Lomb, a leading global eye health company, today announced that it has received Pre-Market Approval from the U.S. Food and Drug Administration for the enVista toric MX60T, the company's first hydrophobic acrylic intraocular lens for astigmatism correction. 'Building on the proven features and benefits of the enVista family of I
6/21/18 - FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes. "Type 1 diabetes is a life-threatening chronic condition requiring continuous and life-long management that can be stressful for patients and their caregivers, especially when the patients are young children," said FDA Comm
6/21/18 - FDA Approves World's First Long-Term Implantable Continuous Glucose Monitoring System for Marketing in United States
Senseonics Holdings, Inc. today announced the U.S. Food and Drug Administration has approved its Premarket Approval application to market the company's Eversense Continuous Glucose Monitoring System to people with diabetes in the United States. "We're very pleased to receive this FDA approval that allows us to make Eversense available in the
6/21/18 - Medtronic Receives FDA Approval for 200mm & 250mm IN.PACT Admiral Drug Coated Balloons
DUBLIN- Medtronic plc today announced that it has received U.S. Food and Drug Administration approval for 200 mm and 250 mm lengths of the IN.PACT Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions in patients with peripheral artery disease. As a result, these lesions become incredibly challenging to treat and often requir
6/21/18 - Medtronic Receives FDA Approval of New Pediatric Indication for the MiniMed(TM) 670G Hybrid Closed Loop System in Children Ages 7-13
DUBLIN- June 21, 2018- Medtronic plc, the global leader in medical technology, today announced that the U.S. Food and Drug Administration has approved the use of the MiniMed (TM) 670 G system in patients with type 1 diabetes seven years of age and older. This newest system by Medtronic features the company's most advanced SmartGuard (TM) technology
6/21/18 - NOCDURNA (desmopressin acetate) Now Approved by U.S. FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
The U.S. Food and Drug Administration granted Ferring Pharmaceuticals Inc. approval to market NOCDURNA , the first sublingual tablet for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Millions of individuals across the country face nocturia each night, many of whom suffer the dayt
6/21/18 - Shire Announces FDA Approval for Label Expansion of CINRYZE (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients
*CINRYZE is the first and only therapy indicated in the U.S. to help prevent angioedema attacks in pediatric patients with hereditary angioedema as young as 6. Dublin, Ireland- Shire plc, the leading global biotechnology company focused on rare diseases, today announced that the U.S. Food and Drug Administration has approved a label expansion for C
6/21/18 - Shire Announces FDA Approval for Label Expansion of CINRYZE? (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients
-CINRYZE is the first and only therapy indicated in the U.S. to help prevent angioedema attacks in pediatric patients with hereditary angioedema as young as 6. Dublin, Ireland Shire plc, the leading global biotechnology company focused on rare diseases, today announced that the U.S. Food and Drug Administration has approved a label expansion for
6/21/18 - Shire Announces FDA Approval for Label Expansion of CINRYZE for Prevention of Attacks in Pediatric HAE
Shire plc has announced that the US Food and Drug Administration has approved a label expansion for CINRYZE to extend to help prevent angioedema attacks in children aged 6 and older with hereditary angioedema. CINRYZE has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE..
6/21/18 - Shire Receives U.S. FDA Approval for New State-of-the-Art Plasma Manufacturing Facility Near Covington, Georgia
Dublin, Ireland- Shire plc, the global biotechnology leader in rare diseases, announced today that the United States Food and Drug Administration has approved the company's first submission for its new plasma manufacturing facility near Covington, Georgia for the production of GAMMAGARD LIQUID 10% Solution, a replacement therapy for primary humo
6/21/18 - Shire Reports FDA Approval For Label Expansion Of CINRYZE
SAINT HELIER- Shire plc announced the U.S. FDA has approved a label expansion for CINRYZE, making it available to help prevent angioedema attacks in children aged 6 years and older with hereditary angioedema. CINRYZE has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with heredi
6/21/18 - Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology
Tandem Diabetes Care , Inc., a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced U.S. Food and Drug Administration approval of the t: slim X2? Insulin Pump with Basal-IQ? technology, a predictive low glucose suspend feature designed to help reduce the frequency and du
6/21/18 - Teligent, Inc. Announces FDA Approval of Fluocinonide Gel, 0.05% [Ethiopian News Agency]
-Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Companys abbreviated new drug application from the U.S. Food and Drug Administration of Fluocinonide Gel, 0.05%. Based on recent IQVIA data from April 2018, the total addressable market for this product is approximately $6.
6/20/18 - AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial
AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase II clinical trial investigating the Company's ROOT OF CANCER technology in patients with glioblastoma multiforme. This will be the third...
6/20/18 - Amphastar Pharmaceuticals receives FDA approval for its injectable heart drug [Arab Finance (Egypt)]
Amphastar Pharmaceuticals Inc announced Tuesday that it has received approval from the US Food and Drug Administration for its heart drug, Isoproterenol Hydrochloride. This approval further strengthens our vertical integration strategy, given that the Active Pharmaceutical Ingredient for this product is manufactured by Amphastar Nanjing...
6/20/18 - B. Braun Receives FDA Clearance for Perfusor Space Syringe Pump [All Iraq News Agency (AIN)]
-B. Braun Medical Inc., a leader in infusion therapy and pain management, announced today that it has received 510 clearance for the wireless 2nd generation software for its Perfusor Space Syringe Pump. This is the first syringe pump with air and road transport in the cleared indications for use. This approval allows us to provide healthcare profes
6/20/18 - Dr. Reddy's Laboratories announces USFDA final approval and launch of Buprenorphine and Naloxone Sublingual Film in the U.S. Market
HYDERABAD- Dr. Reddy's Laboratories Ltd. announced today that it has received final approval from the U.S. Food and Drug Administration and is launching Buprenorphine and Naloxone Sublingual Film, 2 mg/0. 5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone sublingual film, in the United States market.
6/20/18 - Global Allergic Rhinitis Drugs Market Analysis & Forecasts to 2024, With the Market Value Expected to Grow at a CAGR of 3.8%
Among the regions, North America is expected to be the largest market for allergic rhinitis. High incidences of allergic rhinitis in regions like the US, Canada, and other part of North America. In 2017, Catalent Pharma Solutions Limited received approval for Odactra drug, from the U.S. Food and Drug Administration, the first allergen extract to be
6/20/18 - Global Allergic Rhinitis Drugs Market Analysis & Forecasts to 2024, With the Market Value Expected to Grow at a CAGR of 3.8% - ResearchAndMarkets.com
Among the regions, North America is expected to be the largest market for allergic rhinitis. High incidences of allergic rhinitis in regions like the US, Canada, and other part of North America. In 2017, Catalent Pharma Solutions Limited received approval for Odactra drug, from the U.S. Food and Drug Administration, the first allergen extract to be
6/20/18 - India`s first USFDA-approved wound dressing product [Arab Finance (Egypt)]
Being touted as the first US Food and Drug Administration approved wound-care product from India, Axiostat stops uncontrolled bleeding from wounds. Talking about the product, Leo Mavely, founder and CEO of Bengaluru-headquartered Axio Biosolutions, says, while the company was set up about a decade ago, it went commercial only in 2014. The technolog
6/20/18 - Medtronic Receives FDA Approval for 200mm & 250mm IN.PACT Admiral Drug Coated Balloons
DUBLIN- Medtronic plc today announced that it has received U.S. Food and Drug Administration approval for 200 mm and 250 mm lengths of the IN.PACT Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions in patients with peripheral artery disease. As a result, these lesions become incredibly challenging to treat and often requir
6/20/18 - Neovasc Reducer Implanted in First US Patient, Spikes Share Price
The first US patient has officially been implanted with a Neovasc Reducer, a medical device to treat refractory angina developed by Neovasc.. Ryan Gindi among other colleagues from the division of cardiology at the Henry Ford Hospital in Detroit, Michigan. Neovasc first received FDA approval to begin the COSIRA-II IDEA pivotal clinical trial for th
6/20/18 - Teligent Announces FDA Approval of Fluocinonide Gel, 0.05%
Teligent has announced it has received US FDA approval of its new drug application of FLuocinonide Gel, 0.05 percent. Based on recent IQVIA data from April 2018, the total addressable market for this product is approximately $6.2 million. Are You Aware of the FDA's Plans for 2018?
Articles(s): 1 - 25 of 74     Next >>     Go To Page:


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