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
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
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
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
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.
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
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.
Ipsen Biopharmaceuticals reported that Somatuline Depot Injection 120 mg was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.
Cerus said that the U.S. Food and Drug Administration has approved the Intercept Blood System for plasma. In a release, Cerus reported that the Intercept plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection when treating patients requiring therapeutic plasma transfusion.
TRENTON, N.J. The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May. The approval of Zerbaxa on Friday is the second antibiotic approval this year for Cubist Pharmaceuticals, a drugmaker focused on antibiotics. It is being
HEPATIQ LLC announced that they received clearance from the United States Food& Drug Administration to market their HEPATIQ? software. HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images. HEPATIQ LLC is focused on diagnosing the severity of liver disease and predicting adverse clinical outcomes.
Dec. 19 Apira Science, which makes a laser helmet system to grow hair, has received FDA marketing clearance for sales to women. Apira, based in Boca Raton, received FDA clearance for sales to men in 2012. Clearance by the FDA doesn't mean a product works, only that it's not harmful. The iGrow system, which retails for $695, is sold online at igro
LYNPARZA? approved by the US FOOD AND DRUG ADMINISTRATION FOR THE TREATMENT OF ADVANCED OVARIAN CANCER IN PATIENTS WITH GERMLINE BRCA -MUTATIONS AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA? (olaparib) capsules (400mg twice daily) as the first monotherapy for patients with deleterious or suspe
LYNPARZA was approved by the U.S. Food and Drug Administration on December 19, 2014 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. Recognized for its high-touch patient care model, Biologics Oncolo
Teva Pharmaceutical Industries Ltd., announced today that the U.S. Food and Drug Administration approved QNASL 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis in children 4-11 years of age. Todd Mahr, MD, Director of Pediatric Allergy and Immunology at Gundersen Lutheran Medical Center in La Crosse, Wisconsin. QNA
PETAH TIKVA- Teva Pharmaceutical Industries Ltd., Friday said it received FDA approval for lower dose intranasal corticosteroid QNASL 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis in children of 4 to 11 years of age. The drug is expected to become available by prescription in February 2015. The company said QNASL 40 m
Elekta announces that the China Food and Drug Administration has approved Elekta's Flexitron brachytherapy afterloading platform for sale and marketing in China. In China there is a high prevalence of gynecologic cancers, as well lung, breast, colorectum and esophagus cancers. Anming Gong, Elekta's Managing Director for China, says: " Elekta i
EOS imaging reported that the U.S. Food and Drug Administration has approved hipEOS, a 3 D hip arthroplasty planning software based on EOS stereo-radiographic 2 D/3D imaging. Developed by OneFit medical, an EOS imaging group company, the software enables surgeons to perform, using EOS unique stereo- radiographic 2 D/3D low dose images, pre-surgical
Dec. 18 Apira Science, which makes a laser helmet system to grow hair, has received FDA marketing clearance for sales to women. Apira, based in Boca Raton, received FDA clearance for sales to men in 2012. Clearance by the FDA doesn't mean a product works, only that it's not harmful. The iGrow system, which retails for $695, is sold online at igro
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/ 0.5%, the therapeutic equivalent to the reference listed drug, Cosopt Ophthalmic Solution, 2%/ 0.5%, of Oak Pharmaceutica
The FDA has approved Gardasil 9, which is effective against 5 additional strains of HPV. The new formulation was developed by Merck Pharmaceuticals. The FDA says that it has been approved "for the prevention of certain diseases caused by nine types of Human Papillomavirus.