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 The leading web portal for pharmacy resources, news, education and careers July 24, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 24, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 56     Next >>     Go To Page:

7/24/17 - Arrow Seldinger Arterial Catheterization Device Receives FDA Market Clearance
Teleflex Incorporated, a leading global provider of medical technologies for critical care and surgery, has announced today that its Arrow Seldinger Arterial Catheterization Device received market clearance from the U.S. Food and Drug Administration. As we continue to discover new and innovative solutions, the Seldinger Arterial Catheterizati
7/24/17 - Bristol-Myers Squibb Reports Expanded Approval For Yervoy
NEW YORK CITY- Bristol-Myers Squibb Company announced the U.S. FDA has expanded the indication for Yervoy injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. The company said the U.S. FDA approval marks Bristol-Myers Squibb's first pediatric indication fo
7/24/17 - FDA Clears Pesticide-Free Resultz Lice & Egg Elimination Kit
By a News Reporter-Staff News Editor at Pharma Business Week Piedmont Pharmaceuticals announces it has received clearance from the U.S. Food and Drug Administration for its patented, pesticide-free RESULTZ Lice& Egg Elimination Kit, an odorless product that kills and removes head lice and requires only a 5- minute application time.
7/24/17 - Luminex Corporation Receives FDA Clearance for ARIES C. difficile Assay
Luminex Corporation today announced that it has received FDA clearance for the ARIES C. difficile Assay, a moderate complexity, sample to answer test for rapid detection of C. difficile. The ARIES C. difficile Assay detects both toxin A and toxin B, which may reduce the probability of a false negative result from strains that only produce t
7/24/17 - Stryker's MultiGen 2 Radiofrequency Generator Receives FDA 510k Clearance
By a News Reporter-Staff News Editor at Pain& Central Nervous System Week Stryker announced that it has received FDA 510 clearance for its MultiGen 2 RF Generator. This product provides physicians with the efficiency, control and reliability they need when performing radiofrequency ablation, a minimally invasive procedure that can provide lasting
7/24/17 - Teleflex Gets FDA Approval For Arrow Seldinger Arterial Catheterization Device
WASHINGTON- Teleflex Inc., a provider of medical technologies for critical care and surgery, announced that its Arrow Seldinger Arterial Catheterization Device received market clearance from the U.S. Food and Drug Administration. The new Seldinger Arterial Catheterization Device is indicated for short-term use. Teleflex expects to launch the Arrow.
7/24/17 - The U.S. Food & Drug Administration Approves Endari L-glutamine oral powder, the First and Only Treatment for Sickle Cell Disease in Pediatric...
By a News Reporter-Staff News Editor at Clinical Trials Week Emmaus Life Sciences Inc. announced that the U.S. Food and Drug Administration approved Endari? to reduce the severe complications of sickle cell disease in adult and pediatric patients age 5 and older. "The approval of Endari is a significant milestone for the sickle cell patient co
7/24/17 - Uromedica Announces Launch of ProACT? Adjustable Continence Therapy for Men with FDA Approval and Reimbursement Coding
By a News Reporter-Staff News Editor at Pharma Business Week Uromedica, Inc., announced that its FDA approved product, ProACT? Adjustable Continence Therapy for Men, has received a reimbursement code from the Center of Medicare Services and is now commercially available in the United States. "Twelve months after a prostatectomy, one in four me
7/22/17 - FDA approves drug to reduce risk of HER2-positive breast cancer returning [Arab Finance (Egypt)]
The US Food and Drug Administration has approved neratinib as the first extended adjuvant therapy for early-stage, HER2-positive breast cancer. Neratinib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Richard Pazdur, director of FDAs Oncology Center of Excellence and acting director of the Office of Hematolog
7/22/17 - FDA Clears First Neonatal Magnetic Resonance Imaging Device
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging device specifically for neonatal brain and head imaging in neonatal intensive care units. "Although we can use traditional MRI scanners to image
7/22/17 - FDA clears first neonatal magnetic resonance imaging device [Syrian Arab News Agency]
Today, the US Food and Drug Administration cleared the first magnetic resonance imaging device specifically for neonatal brain and head imaging in neonatal intensive care units. Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges, said Vasu
7/22/17 - GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (Belimumab) for Systemic Lupus Erythematosus
GlaxoSmithKline issued the following news release:. GSK announced today that the US Food and Drug Administration has approved a new subcutaneous formulation of Benlysta for the treatment of adult patients with active, autoantibody positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus is the most common form of lupus, a ch
7/22/17 - MRI approved for young infants in intensive care [Sport360]
The first magnetic resonance imaging, or MRI, device designed to scan the heads and brains of newborns in intensive care units has been approved by the U.S. Food and Drug Administration. The Embrace Neonatal MRI System is the first unit approved to provide these scans of critically ill newborns, the FDA said Thursday in a news release. The system i
7/22/17 - NERLYNX (neratinib) Tablets Approved for HER2+ Breast Cancer in Extended Adjuvant Setting
McKesson issued the following news release:. Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected to be in the limited distribution network for Puma Biotechnology, Inc.' s new product, NERLYNX, a kinase inhibitor approved by the U.S. Food and Drug Administration. "We are pleased to b
7/22/17 - US FDA approves 1st neonatal MRI device [Philippines News Agency]
"Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges," Vasum Peiris, chief medical officer for pediatrics and special populations at the FDA's Center for Devices and Radiological Health, said in a statement. The FDA explained that the new d
7/21/17 - Breckenridge Announces Final Approval for Omeprazole Delayed-Release Capsules
By a News Reporter-Staff News Editor at Drug Week Breckenridge Pharmaceutical, Inc. announced it has received U.S. Food and Drug Administration final approval of its abbreviated new drug application for Omeprazole delayed-release capsules, USP, in 10 mg, 20 mg, 40 mg strengths, which will be manufactured and supplied by its parent company, Labora
7/21/17 - FDA clears first neonatal magnetic resonance imaging device
Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)...
7/21/17 - FDA Clears First Neonatal MRI Device
The FDA has cleared the first MRI device specifically for neonatal brain and head imaging in neonatal intensive care units. In fact, the Embrace neonatal MRI system, manufactured by Aspect Imaging Ltd., is designed specifically for imaging of the neonatal head.
7/21/17 - Gileads latest hep C combo approved in US [Sudan Tribune]
The FDA approved Vosevi, offering a single-tablet regimen for retreatment of adults with any of the six major hepatitis C genotypes who have previously received an NS5a inhibitor-containing regimen. Gilead is becoming a victim of its own success in hepatitis, as an increasing number of patients have been cured with its therapies and those from riva
7/21/17 - Gileads Vosevi receives FDA approval for re-treatment of chronic HCV [Arab Finance (Egypt)]
The US Food and Drug Administration has approved biotechnology company Gilead Sciences Vosevi tablets for the re-treatment of chronic hepatitis C virus infection. Gilead Sciences president and chief executive officer Dr John Milligan said: The evolution of Gileads portfolio of HCV single-tablet regimens has been driven by our commitment to address.
7/21/17 - GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus
GSK announced today that the US Food and Drug Administration has approved a new subcutaneous formulation of Benlysta for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus is the most common form of lupus, a chronic, incurable autoimmune disease producing...
7/21/17 - NERLYNX?(neratinib) Tablets Approved for HER2+ Breast Cancer in the Extended Adjuvant Setting
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected to be in the limited distribution network for Puma Biotechnology, Inc. s new product, NERLYNX, a kinase inhibitor approved by the U.S. Food and Drug Administration. NERLYNX is indicated for the extended adjuvant treatment of adul
7/21/17 - SillaJen : China's FDA Oks To Commence Phase 3 Trial For Oncolytic Immunotherapy
HONG KONG- SillaJen, Inc. and Lee's Pharmaceutical Holdings Ltd. announced approval by the China Food and Drug Administration to conduct a Phase 3 clinical trial for advanced liver cancer using its oncolytic immunotherapy called Pexa-Vec, the PHOCUS study. SillaJen and Lee's Pharmaceutical participated in a first of its kind Chinese Center for Drug
7/21/17 - Summary: Senate Subcommittee Approves FY2018 Agriculture Appropriations Bill
Jeff Merkley, D- Ore., ranking Democratic member of the Senate Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, issued the following news release:. The fiscal year 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill provides a total discretion
7/21/17 - Teligent, Inc. Announces FDA Approval Of Erythromycin Topical Gel USP, 2%
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application from the U.S. Food and Drug Administration of Erythromycin Topical Gel USP, 2%. "Erythromycin Topical Gel USP, 2% is Teligent's third FDA approval in 2017,'' commented Jason Gren
Articles(s): 1 - 25 of 56     Next >>     Go To Page:


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