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 The leading web portal for pharmacy resources, news, education and careers September 30, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 30, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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9/26/14 - Clear Guide Medical Receives FDA 510(k) Clearance on First Product, the CLEAR GUIDE ONE
Clear Guide Medical announced that its first clinical product, the CLEAR GUIDE ONE, was cleared by the United States' Food and Drug Administration on September 19, 2014. CEO Dorothee Heisenberg stated, "We are extremely pleased that the FDA's 510 process moved along so quickly, and that we are close to receiving our CE and Health Canada certifica
9/26/14 - pSivida Corp. Reports FDA Approval of ILUVIEN for Diabetic Macular Edema
pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the U.S. Food and Drug Administration has approved ILUVIEN for the treatment of diabetic macular edema. FDA approval of ILUVIEN entitles pSivida to a $25 million milestone from its licensee Alimera Sciences. pSi
9/26/14 - United States : FDA clears glucose monitoring system for use in hospital critical care units [TendersInfo (India)]
This is the first blood glucose monitoring system cleared by FDA for use in these patients. The Nova StatStrip Glucose Hospital Meter System is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients. The FDA determined that the Nova StatStrip Glucose Hospital Meter Sys
9/25/14 - AbbVie gets new approval for its drug Humira
NEW YORK AbbVie said Thursday that U.S. regulators approved its drug Humira as a treatment for Crohn's disease in children. The Food and Drug Administration cleared Humira as a treatment for moderate to severe Crohn's disease in children ages 6 and older when those children haven't been helped by other treatments, AbbVie said. AbbVie Inc. shares
9/25/14 - AbbVie's HUMIRA (adalimumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderately to Severely Active Crohn's Disease
AbbVie announced today that the U.S. Food and Drug Administration has approved HUMIRA for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for
9/25/14 - ACOR Opens Wallet, CYNO Gets FDA Nod, INO To Advance Ebola Vaccine Study
Cynosure Inc.' s flagship PicoSure Picosecond Laser Workstation with its new disposable energy delivery system, the FOCUS lens array, has received FDA clearance for the treatment of wrinkles. The PicoSure system gained FDA clearance to treat acne scars last month. The device also has FDA clearance for the removal of tattoos and benign pigmented les
9/25/14 - Blaze Bioscience Announces Initiation of Phase 1b Brain Cancer Program for Tumor PaintTM BLZ-100
Blaze Bioscience, Inc., a biotechnology company focused on guided cancer therapy, announced today that the company has received clearance from the United States Food and Drug Administration for the first Phase 1 clinical study under their Tumor Paint BLZ-100 Investigational New Drug application. The Phase 1 b study entitled A Phase 1 Dose...
9/25/14 - Boehringer Ingelheim Announces FDA Approval of Spiriva Respimat (tiotropium bromide) Inhalation Spray for the Maintenance Treatment of COPD
Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration approved Spiriva Respimat inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema and to reduce exacerbations in.
9/25/14 - CivaTech Oncology Secures FDA Approval for CivaSheet Brachytherapy Device [Professional Services Close - Up]
CivaTech Oncology has received FDA clearance on its bioabsorbable, planar radiation device. Brian J. Moran, Medical Director of Chicago Prostate Center believes the CivaSheet "potential could be huge. "We are very excited about the beneficial impact this can have for all of the patients whom are candidates for this new treatment option," said Civa
9/25/14 - FDA clears glucose monitoring system for use in hospital critical care units
This is the first blood glucose monitoring system cleared by FDA for use in these patients. The Nova StatStrip Glucose Hospital Meter System is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients. The FDA determined that the Nova StatStrip Glucose Hospital Meter Sys
9/25/14 - IMRIS neurosurgical HFD rocker arm receives FDA clearance
By a News Reporter-Staff News Editor at Politics& Government Week IMRIS Inc. announced a new rocker arm accessory that expands choices for neurosurgeons to select the best fixation suited for patients during procedures using intraoperative imaging inside the VISIUS Surgical Theatre. "Providing these optimal tools for neurosurgeons will allow mor
9/25/14 - JayMac Pharmaceuticals Releases Case Study on Use of EnLyte in Adolescent Depression.
There is only one drug FDA approved for use in this group, Prozac/Fluoxetine, and it comes with common SSRI side effect warnings: nausea, headaches, anxiety, insomnia, drowsiness, and loss of appetite, as well as withdrawal reactions such nausea, nervousness, and insomnia when the drug is stopped. According to Dr. Farah, "We finally have an agent t
9/25/14 - Lannett Gets FDA Approval of Oxycodone Hydrochloride Oral Solution [Professional Services Close - Up]
Lannett Company recently reported that it has received approval from the U.S. Food and Drug Administration of its abbreviated new drug application for oxycodone hydrochloride oral solution USP, 100 mg per 5 mL. "Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, is an important and long awaited addition to our pain management franchise an
9/25/14 - Nova StatStrip Glucose Hospital Meter System Receives FDA Clearance for Intensive Care Use
StatStrip Glucose is now the ONLY glucose monitoring system that is FDA- cleared for the detection and management of dysglycemia throughout all professional healthcare settings including critical care. The announcement comes after an extensive, four-year project with the FDA and five prestigious university medical centers. Because of the unacceptab
9/25/14 - Scorpion venom-based Tumor Paint approved for clinical trial
With approval from the FDA now secured, Blaze Bioscience, a young biotech company, will move forward with its plans to inject 21 cancer patients with so-called Tumor Paint a cancer cell-targeting compound derived from the venom of deathstalker scorpions. Jim Olson and his team of scientists say Tumor Paint, when injected into the human brain, coa
9/24/14 - Cynosure Receives Expanded FDA Clearance to Market PicoSure for Treatment of Wrinkles
Cynosure, Inc., a leader in laser- and light-based aesthetic treatments for non-invasive and minimally invasive applications, today announced that it has received FDA 510 clearance to market its flagship PicoSure Picosecond Laser Workstation for the treatment of wrinkles with the Company's new disposable energy delivery system, the FOCUS lens arr
9/24/14 - FDA Approves Use of Menactra Vaccine for Booster Immunization Against Potentially Deadly Disease
By a News Reporter-Staff News Editor at Biotech Week Sanofi Pasteur, the vaccines division of Sanofi, announced that the U.S. Food and Drug Administration approved use of Menactra for booster vaccination against meningococcal disease in persons 15 years through 55 years of age. "The FDA's approval of the Menactra booster vaccination gives health
9/24/14 - FDA Clears Glucose Monitoring System For Use In Hospital Critical Care Units
This is the first blood glucose monitoring system cleared by FDA for use in these patients. The Nova StatStrip Glucose Hospital Meter System is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients. The FDA determined that the Nova StatStrip Glucose Hospital Meter Sys
9/24/14 - First-Ever Conception Assistance Device FDA-Cleared for Home Use Launches U.S. Over-the-Counter Sales
Rinovum Women s Health announced today that The Stork OTC the only home-use conception assistance device on the market cleared by the FDA for over-the-counter sales is available without a prescription in stores and online at www.storkotc.com. It is the only FDA- cleared product that provides consumers a safe, easy way to perform cervica
9/24/14 - Keryx Biopharmaceuticals receives FDA approval of ferric citrate
By a News Reporter-Staff News Editor at Biotech Week Keryx Biopharmaceuticals, Inc. announced that the U.S. Food and Drug Administration approved Ferric Citrate for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. "We are thrilled with the FDA's decision to approve Ferric Citrate, and look forward to br
9/24/14 - Lannett Updates on FDA Approval of Oxycodone Hydrochloride Oral Solution [Manufacturing Close - Up]
Lannett Company recently reported that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL. "Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, is an important and long awaited addition to our pain management franchise an
9/24/14 - Mazor Robotics: China Food and Drug Administration Approves Renaissance Systems [Professional Services Close - Up]
Mazor Robotics reported that the China Food and Drug Administration has approved the Company's Renaissance system, a surgical guidance system that enables surgeons to conduct spine surgeries. In a release, the Company noted its distribution partner in China is Cicel. "Receiving CFDA's approval for marketing the Renaissance system in China is a sig
9/24/14 - Molecular Templates Announces FDA Approval of Investigational New Drug Application for CD20 Internalizing Immunotoxin MT-3724
By a News Reporter-Staff News Editor at Biotech Week Molecular Templates, Inc., a biopharmaceutical company focused on the discovery and development of a new class of targeted biologic therapies, announced that the US Food and Drug Administration has approved the Company's Investigational New Drug Application to initiate clinical studies for MT-3
9/24/14 - Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle (Estradiol Transdermal System)
MIAMI and NEW YORK, Sept. 24, 2014/ PRNewswire/ Noven Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has approved a new indication with a new dose of Minivelle for the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms due
9/24/14 - United States : Personalized Care from Disease Detection through Treatment Assessment: GE Healthcare Announces FDA Clearance of Discovery IQ [TendersInfo (India)]
GE Healthcare today announced U.S. FDA 510 clearance of its Discovery IQ PET/CT system, enabling both outstanding image quality and intelligent quantitation to help physicians deliver the best possible patient outcomes. I m excited about the recent FDA clearance of Discovery IQ, which will help physicians achieve their primary mission of delivering
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