By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week HeartFlow Inc., a pioneer in personalized medical technology for cardiovascular disease, announced that it received de novo clearance from the U.S. Food and Drug Administration for its FFRCT technology. HeartFlow FFRCT is the first and only non-invasive imaging technology for
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration approved the intravenous administration of Erwinaze . "Administration of Erwinaze through an intravenous infusion provides physicians another option for patients, including those who cannot tolerate intramuscular injections," said Jeffrey Tobias, M.D., executiv
Dec. 19 Eight hospitals in Western Pennsylvania were penalized by the federal government because patients were infected while being treated at their facilities. The hospitals are among more than 700 across the country whose Medicare reimbursement rates will be cut by 1 percent for not reducing hospital-acquired infections, the Department of Healt
The U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK?, an all-oral, interferon-free treatment, with or without ribavirin, for the treatment of patients with chronic genotype 1 hepatitis C virus infection, including those with compensated cirrhosis. "We are proud of the work of our research and development organization to bri
Amarantus BioScience Holdings, Inc., a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has applied to the U.S. Food& Drug Administration for Orphan Drug Designation for its investigation
December 20 is the deadline for enrollment at the NY State of Health online marketplace for residents who want their health coverage to begin January 1, 2015. With the current enrollment window closing soon, Seth Diamond, Chief Operating Officer at MetroPlus Health Plan, answered questions that many New Yorkers still have about the Affordable Care
TRENTON, N.J. U.S. regulators on Friday granted accelerated approval to the first in a new class of targeted drugs for ovarian cancer, Lynparza from British drugmaker AstraZeneca PLC. The Food and Drug Administration also approved a companion diagnostic test from Myriad Genetics Inc. of Salt Lake City called BRACAnalysis CDx. Richard Pazdur, dir
DRUG maker AstraZeneca rewarded the faith of investors in the company yesterday after its pioneering ovarian cancer drug was approved for use across Europe. The FTSE 100 pharmaceutical company highlighted its industry-leading cancer drugs earlier this year to counter a 70 bn takeover bid from US rival Pfizer. News of the European Commission'' s a
LONDON- AstraZeneca PLC said Friday that the US Food and Drug Administration has approved Lynparza as a monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. The FDA approval follows the approval of the drug in the EU as
Bio2 Technologies, Inc. announced today that it has received 510 clearance from the U.S. Food and Drug Administration for its CLM Bioactive Scaffold. Paul Nichols, President and Chief Executive Officer of Bio2 Technologies, stated "the receipt of FDA market clearance paves the way for U.S. commercialization of our first product line, resorbable b
Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the launch of the BIOSENSE WEBSTER ADVANTAGE SM Program, an outcomes-based, risk-sharing program for U.S. hospitals that reinforces the significant patient benefits demonstrated by the company s THERMOCOOL SMARTTOUCH Catheter.
Breckenridge Pharmaceutical, Inc. announced today that it has entered into a multi-product agreement with MSN Laboratories Pvt. Ltd. under which Breckenridge and MSN expect to commercialize several new ANDAs. Under the terms of the agreement, MSN will develop, manufacture, and supply the products exclusively to Breckenridge for the U.S. market, a
Centene Corporation announced today that its behavioral health management company, Cenpatico of Arizona, in partnership with University of Arizona Health Plan, has been selected by the Arizona Department of Health Services/Division of Behavioral Health Services to be the Regional Behavioral Health Authority for the new southern geographic service
Milan, Italy, December 19, 2014- Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies announced today that it expects the EU Committee for Medicinal Products for Human Use to disclose their opinion regarding approval of safinamide for marketing in the EU in the course of today. Following the subm
Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area, announced today that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve
CHMP recommends Approval of XadagoTM. Milan, Italy, December 19, 2014- Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area, announced today that the EU Committee for Medicinal P
Cubist Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration approved ZERBAXA? for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal infections caused by designated susceptible Gram-negative bacteria. Both trials met the pre-specified primary endpoints agreed upon with the FDA.
A new formulation of Acetadote Injection was developed by Cumberland Pharmaceuticals Inc. as part of a Phase IV commitment by the Company in response to a request by the Food and Drug Administration to evaluate the reduction of ethylene diamine tetraacetic acid from the product's formulation. The new formulation was listed in the FDA Orange Book
Data on Hemodialysis Described by Researchers at University of Michigan. By a News Reporter-Staff News Editor at Health& Medicine Week Investigators discuss new findings in Hemodialysis. Our news editors obtained a quote from the research from the University of Michigan, "Methods and Findings: We assessed the Human Mortality Database and 206,374
South Africa's Deputy Minister of Correctional Services Thabang Makwetla has said that correctional facilities in South Africa are not the "disease-infested", poorly serviced centres of public perception. Prisoners in South Africa have access to better healthcare services than the general public, the Deputy Minister of Correctional Services, Thaban
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs primarily in the infectious disease field, today announced the U.S. Food and Drug Administration has approved AbbVie s VIEKIRA PAK? with or without ribavirin for the treatment of genotype 1 patients with chronic hep
Radius Health, Inc. announced today that the U.S. Food and Drug Administration has accepted the Company's Investigational New Drug application for its investigational drug RAD1901, a tissue-selective estrogen receptor degrader being developed for potential use in metastatic breast cancer. We also are continuing discussions with the European...
TRENTON, N.J. Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie. The Food and Drug Administration on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie Inc. of North Chicago, Illinois. It includes a combinatio
LONDON- British drugmaker AstraZeneca PLC said Friday that the US Food and Drug Administration has approved Lynparza capsules, 400 mg twice daily, as the first monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.
Bovie Medical has received FDA 510 approval for the Bovie Ultimate generator. According to a release from Bovie Medical, the Bovie Ultimate is a high frequency electrosurgical generator that can be used for delivery of RF energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures.