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 The leading web portal for pharmacy resources, news, education and careers July 30, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 30, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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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
7/26/16 - Progenics Receives $50 Million Milestone Payment Following FDA Approval of RELISTOR Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-cancer Pain
Progenics Pharmaceuticals, Inc. announced today that it has received a $50 million milestone payment from its worldwide collaboration partner, Valeant Pharmaceuticals International, Inc., resulting from the US Food and Drug Administration's marketing approval last week of RELISTOR Tablets for the treatment of opioid-induced constipation in...
7/25/16 - AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR? (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C
AbbVie, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved a New Drug Application for VIEKIRA XR? extended-release tablets. "AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitme
7/25/16 - Enanta Announces the U.S. Food and Drug Administration has approved AbbVie's New, Once-Daily VIEKIRA XR? (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C Virus
Enanta Pharmaceuticals, Inc.,, a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration has approved AbbVie s New Drug Application for VIEKIRA XR? extended release tablets. Our collaborative partner
7/25/16 - Loop Industries Receives Positive Opinion Letter Confirming FDA Approval of Its Tertiary PET Recycling Process
Loop Industries, Inc., an environmentally responsible manufacturer of Purified Terephthalic Acid and Mono Ethylene Glycol, is pleased to announce that it has received a positive opinion letter from its FDA counsel confirming that the Company's proprietary depolymerization technology enables a tertiary recycling process which the FDA has concluded..
7/25/16 - 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...
According to news originating from Katowice, Poland, by NewsRx correspondents, research stated, " Target- oriented drug discovery is the main research paradigm of contemporary drug discovery. Our news journalists obtained a quote from the research from the University of Silesia, "This can result in a higher molecular complexity, in particular, the
7/25/16 - SinuSys? Corp. Receives FDA Clearance for the Vent-Os Sinus Dilation Family of Devices
By a News Reporter-Staff News Editor at Pharma Business Week SinuSys Corporation, an innovative sinus health company, announced receipt of FDA clearance for a full family of sinus dilation devices, adding two new devices that will expand the company's portfolio of low-pressure, self-expanding dilation devices to enable dilation of the frontal and
7/25/16 - Supply Of (ex)drug Eluting Stents Fda And Dcgi Approved First Generation [TendersInfo (India)]
Tenders are invited for Supply of Drug Eluting Stents Fda And Dcgi Approved First Generation, Drug Eluting Stents Fda And Dcgi Approved Second Generation, Drug Eluting Stents Fda And Dcgi Approved Third Generation, Drug Eluting Stents Ce And Dcgi Approved, Drug Eluting Stents Dcgi Approved, Drug Eluting Coronary Stents Tapering, Drug Eluting Corona
7/24/16 - FDA approves Abbott's Absorb bioresorbable stent, the only fully dissolving heart stent
By a News Reporter-Staff News Editor at Heart Disease Weekly Abbott announced that the U.S. Food and Drug Administration has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States. Absorb is the only fully dissolv
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