New Assay To Help In The Diagnosis Of Mastocytosis Approved By FDA
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FDA approves TMI’s Glider PTCA Catheter
TriReme Medical, Inc. (TMI) today announced approval by the U.S. Food and Drug Administration (FDA) of the Glider PTCA Catheter, indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion.
Glytec receives FDA clearance for Glucommander 2.0 Enterprise software
Glytec, LLC, headquartered in Greenville, SC, announced today that its Glucommander 2.0 Enterprise software has been cleared by the FDA for pediatric use, ages 2 - 17.
FDA clears test developed in partnership with VCU researcher
(Virginia Commonwealth University) The Food and Drug Administration has approved a new test to help physicians diagnose a group of rare cell disorders. The test, or assay, was developed by an expert at Virginia Commonwealth University in the field of mast cells.
New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA
MONDAY, May 21 (HealthDay News) -- The new blood thinner Xarelto appears to lower the chances of potentially fatal blood clots in high-risk heart patients, a U.S. Food and Drug Administration review has found. The review came in briefing documents that were filed Monday in advance of an FDA ...
Generic Versions Of Blood Thinning Plavix Approved By FDA
Generic versions of blood-thinning medication - Plavix (clopidogrel bisulfate) - have been approved by the FDA (Food and Drug Administration). Clopidogrel bisulfate reduces the likelihood of blood platelets clumping together and forming clots in blood vessels, resulting in a lower risk of stroke and heart attack. Clopidogrel is approved by ...
FDA gives patients less-expensive option, approves first generic versions of Plavix
Patients taking the popular blood thinner Plavix now have the option of getting a less-expensive pill, following the approval Thursday of the first generic versions in the U.S. That's because the patent for Plavix, the world's second-best-selling medicine, just expired. Plavix is taken by millions of people every day to ...
Actavis receives FDA approval for Ropinirole ER Tablets
Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Ropinirole Extended-Release Tablets, 2mg, 4mg, 6mg, 8mg and 12mg, a generic equivalent to GlaxoSmithKline's Requip XL.
Drug Approval Faster In US FDA Than Its European Or Canadian Counterparts
Although the drug approval process in the U.S. has been perceived as too slow, the nation approves new drug treatments faster and earlier than Europe and Canada, according to researchers at Yale School of Medicine. The study, conducted by Nicholas Downing, a second-year medical student and Joseph S. Ross, ...
FDA Approves Generic Versions of Plavix
By Steven Reinberg HealthDay Reporter THURSDAY, May 17 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved generic versions of the blood thinner Plavix (clopidogrel), making the widely used medication more affordable for those patients who need it. ...
US FDA Ahead Of Canada, Europe In Drug-Approval Race
The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow. Led by ...
Established Cancer Vaccine Works Better In Tandem With FDA-Approved Kidney Transplant Drug
A team from the Perelman School of Medicine and the Abramson Family Cancer Research Institute at the University of Pennsylvania found that the FDA-approved drug daclizumab improved the survival of breast cancer patients taking a cancer vaccine by 30 percent, compared to those patients not taking daclizumab. This proof-of-concept study ...