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 The leading web portal for pharmacy resources, news, education and careers July 29, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 29, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 34     Next >>     Go To Page:

7/29/16 - Fosun Pharma to buy Indian drug maker for up to US$1.26bn [ET Net News (China)]
Shanghai Fosun Pharmaceutical and Fosun. US $1,261.37 million to acquire about 79.997% equity interest in Gland Pharma Limited and. first injectable drug manufacturer in India which has been approved by the FDA and has.
7/29/16 - Galderma Announces FDA Approval of Full Prescription-Strength Differin Gel For Over-the-Counter Acne Use
By a News Reporter-Staff News Editor at Drug Week Galderma, a global leader focused on medical solutions in skin health, announced that its U.S. affiliate, Galderma Laboratories, L.P. received approval from the U.S. Food and Drug Administration for Differin Gel as an over-the-counter treatment for acne. It also marks the first new, FDA- approved
7/29/16 - InVivo Therapeutics Announces Update on the INSPIRE Study and FDA Approval of Expansion of the Study to 20 Evaluable Patients
By a News Reporter-Staff News Editor at Health& Medicine Week InVivo Therapeutics Holdings Corp. today provided an update on the INSPIRE study of the Neuro-Spinal Scaffold?. The implantation was performed by Vidant Medical Group neurosurgeons Stuart Lee, M.D., the Principal Investigator at the site, and Hilal Kanaan, M.D., approximately 40 hour
7/29/16 - Novocure Receives FDA Approval for Second Generation Optune System
By a News Reporter-Staff News Editor at Drug Week Novocure announced that the U.S. Food and Drug Administration approved its premarket approval supplement application for Novocure's second generation Optune system. Novocure started offering the second generation Optune system to patients in Germany in October 2015 and has since made it available
7/28/16 - FDA approves lixisenatide as AdlyxinTM for the treatment of adults with type 2 diabetes in the U.S.
Lixisenatide has been approved in the U.S. under the brand name Adlyxin TM indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes, including in combination with oral anti-diabetes medication and/or basal insulin. There are an estimated 27.5 million adults with type 2 diabetes in the U.S., and the U.S market co
7/28/16 - FDA Approves Sanofi's Adlyxin For Treatment Of Adults With Type 2 Diabetes
PARIS- Sanofi said that the U.S. Food and Drug Administration approved Adlyxin or lixisenatide, a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. The approval of Adlyxin
7/28/16 - Sanofi receives FDA approval of Adlyxin TM for treatment of adults with Type 2 Diabetes
U.S. Food and Drug Administration (FDA) have approved Sanofi's Adlyxin TM (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes...
7/28/16 - Sanofi Receives FDA Approval of AdlyxinTM for Treatment of Adults with Type 2 Diabetes
Sanofi announced today that the U.S. Food and Drug Administration approved Adlyxin TM, a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. "The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people livin
7/28/16 - Special Notice - Development of an approved Food and Drug Administration (FDA) TBI Assay Cartridge for the i-STAT- , using UCHL1 and GFAP protein biomarkers
Special Notice- Development of an approved Food and Drug Administration TBI Assay Cartridge for the i-STAT-, using UCHL1 and GFAP protein biomarkers. Office Address: Department of the Army; U.S. Army Medical Research Acquisition Activity; Attn: MCMR-AAA820 Chandler Street Frederick, MD 21702-5014 MD 21702-5014. Subject: Development of an approved F
7/27/16 - 4WEB Medical Announces FDA Clearance of Lateral Spine Truss System
4 WEB Medical, the industry leader in 3 D printed orthopedic implants, announced today that the company has received 510 K clearance from the FDA for its lateral interbody fusion device. "The Lateral Spine Truss System represents a significant advancement in treatment options for lateral spine surgery," said Frank Cammisa, MD, Professor and Chie
7/27/16 - AbbVie receives FDA approval for new Hepatitis C drug
US FDA has approved Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of chronic genotype 1 (GT1) hepatitis C...
7/27/16 - BioTelemetry, Inc. Announces FDA Approval of Its Next Generation Device, the MCOT Patch [Cyprus Mail]
-BioTelemetry, Inc., the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, is pleased to announce that it has received U.S. Food and Drug Administration 510 clearance of its next generation Mobile Cardiac Outpatient Telemetry device, the MCOT Patch.
7/27/16 - ClearFlow Launches FDA-Cleared PleuraFlow System for Pediatric Cardiothoracic Surgery [Moj News Agency (Iran)]
ClearFlow, Inc., a medical device company based in Anaheim, California, has announced that its PleuraFlow Active Clearance Technology is now available for the treatment of pediatric cardiothoracic surgery patients. After receiving clearance from the United States Food& Drug Administration earlier this year for expanded Indications for Use with the.
7/27/16 - Companion Medical Receives FDA Clearance for Smart Insulin Delivery System
Companion Medical, a leader in the development of advanced technology to improve diabetes care, announced today that the U.S. Food and Drug Administration has granted 510 clearance for the InPen system, its wireless-enabled insulin pen and proprietary mobile application. The InPen is the first and only FDA- cleared SmartPen? that includes te
7/27/16 - FDA OK's 785-nm PicoWay Picosecond Laser
Syneron Medical Ltd announces that the ultrashort, 785-nm wavelength of its PicoWay picosecond laser has received approval from the US Food and Drug Administration (FDA).
7/27/16 - GeneOne Life Science Doses First Subjects in Zika Vaccine Clinical Trial [Palestine Chronicle, The]
-GeneOne Life Science, Inc. today announced the dosing of the first subjects in its multi-center Phase I trial to evaluate the Zika DNA vaccine. GeneOne has received approval from both the US FDA and Health Canadas Health Products and Food Branch to conduct the clinical trial for GLS-5700. The study will be conducted at clinical sites in Miami, Uni
7/27/16 - New treatment for low back pain: minimally invasive procedure receives FDA clearance
According to the National Institutes of Health, 80 percent of adults will experience low back pain some time in their lives. Laura Donlon, 48, of Monroe had been dealing with low back pain for five years before she found out about a back pain study at Beaumont Hospital in Royal Oak, Michigan. "In 25 years of practicing orthopedics, this is the mos
7/27/16 - Researchers at University of Silesia Report New Data on Computer-Aided Design (The analysis of the market success of FDA approvals by probing top 100...
By a News Reporter-Staff News Editor at Computer Weekly News Data detailed on Computer-Aided Design have been presented. According to news originating from Katowice, Poland, by VerticalNews correspondents, research stated, " Target- oriented drug discovery is the main research paradigm of contemporary drug discovery. For more information on this
7/27/16 - Sanofi Receives FDA Approval of AdlyxinTM for Treatment of Adults with Type 2 Diabetes
Sanofi Receives FDA Approval of Adlyxin (TM) for Treatment of Adults with Type 2 Diabetes- Adlyxin (TM) is approved as Lyxumia in more than 60 countries- Paris, France- July 28, 2016- Sanofi announced today that the U.S. Food and Drug Administration approved Adlyxin (TM), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunc
7/27/16 - Vertex Reports Second Quarter 2016 Financial Results
Vertex Pharmaceuticals Incorporated today reported consolidated financial results for the quarter ended June 30, 2016 and reviewed recent progress with its approved and investigational cystic fibrosis medicines. "Just over a year ago, we received FDA approval for ORKAMBI, marking the most significant step to date in our journey to develop new medi
7/26/16 - BioTelemetry, Inc. Announces FDA Approval of Its Next Generation Device, the MCOT? Patch
BioTelemetry, Inc., the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, is pleased to announce that it has received U.S. Food and Drug Administration 510 clearance of its next generation Mobile Cardiac Outpatient Telemetry? device, the MCOT? Patch.
7/26/16 - Chinas First HPV Vaccine Approved [Moj News Agency (Iran)]
GSK China`s Cervarix vaccine has been approved by the China Food and Drug Administration as the first human papillomavirus vaccine licensed for use in China. Cervarix is registered in China for use in girls and women aged 9-25 years with a three-dose schedule. A clinical trial conducted in China, involving more than 6,000 subjects who received Cerv
7/26/16 - GeneOne Life Science Doses First Subjects in Zika Vaccine Clinical Trial
GeneOne Life Science, Inc. today announced the dosing of the first subjects in its multi-center Phase I trial to evaluate the Zika DNA vaccine. GeneOne has received approval from both the US FDA and Health Canada's Health Products and Food Branch to conduct the clinical trial for GLS-5700. The study will be conducted at clinical sites in Miami, Uni
7/26/16 - Instrumentation Laboratory Receives US FDA Clearance For New HemosIL HIT-Ab(PF4-H) Assay
Instrumentation Laboratory today announced the 510 clearance of the HemosIL HIT-Ab assay for use on ACL TOP Family Hemostasis Testing Systems, by the US Food and Drug Administration. The first, fully automated, on-demand assay for Heparin-Induced Thrombocytopenia on a Hemostasis testing system, HemosIL HIT-Ab detects antibodies associated with
7/26/16 - LSK BioPharma Announces Successful Outcome from End-of-Phase 2 meeting with FDA
The FDA had no major objections to LSKB's global phase 3 pivotal-trial study design for apatinib in patients with advanced gastric cancer. "We had a good, collaborative meeting with the U.S. FDA," said Dr. Sung Chul Kim, President of LSK BioPharma, "we received valuable guidance that we expect will help us to quickly bring apatinib to market and p
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