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Latest US Food and Drug Administration Stories

2010-07-28 17:50:00

WILMINGTON, Del., July 28 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended the FDA approve AstraZeneca's investigational drug ticagrelor for the reduction of thrombotic events in patients with Acute Coronary Syndromes (ACS). (Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO ) (Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO ) The...

2010-07-27 16:00:00

ANAHEIM, Calif., July 27 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received clearance from the US Food and Drug Administration (FDA) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns. Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates. The new tBili assay is performed on IL's GEM Premier 4000 critical care analyzer. It allows clinicians to...

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2010-07-11 07:25:00

American scientists have developed "artificial blood" that could soon be used to treat soldiers who are wounded during battle. The artificial blood is created by taking cells from umbilical cords and using a machine to imitate the way bone marrow works to produce mass quantities of usable units of red blood cells. Producing the genetically-engineered blood is known as "Ëœblood pharming'. The program was launched in 2008 by the Pentagon's experimental sector, Darpa, to find a way...

2010-07-08 05:00:00

AMSTERDAM, July 8 /PRNewswire/ -- Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR(TM) in the United States. Kiadis Pharma is currently enrolling patients in a multinational, pivotal clinical study at hospitals in Europe and Canada. With the approval of the IND, US hospitals will also participate in...

2010-06-17 16:10:00

WAYNE, N.J., June 17 /PRNewswire/ -- In a June 16, 2010 proceeding before Judge Virginia Kendall in US Federal Court in the Northern District of Illinois, Teva Pharmaceuticals USA Inc. admitted that the Physician Prescribing Information included with packages of its oral contraceptive Gianvi(TM), falsely claimed that the ethinyl estradiol in the product was stabilized by Bayer's patented "betadex as a clathrate" formulation, and in fact, that Gianvi does not have Bayer's patented...

2010-06-10 19:15:00

EAST HANOVER, N.J., June 10 /PRNewswire/ -- Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in...

2010-06-05 16:39:00

EAST HANOVER, N.J., June 5 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that results from a Phase II study show Afinitor® (everolimus) tablets is the first medication in a clinical trial to decrease the size of subependymal giant cell astrocytomas (SEGAs), benign brain tumors associated with tuberous sclerosis (TS) (1,2). In this study of 28 patients presented today at the 46th American Society of Clinical Oncology (ASCO) annual...

2010-06-02 07:00:00

SAN DIEGO, June 2, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the US Food and Drug Administration (FDA) has notified the company of the tentative scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin is Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance...

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2010-05-12 06:15:00

The US Food and Drug Administration (FDA) plans to look into US pharmacy chain Walgreens after the company announced it will start selling genetic testing kits to help people asses their risk of inherited diseases. Walgreens said Tuesday it plans to begin stocking the kits this week. The kits are made by Pathway Genomics out of San Diego, California. The deal would be the first of its kind to put such tests in local pharmacies. But according to the FDA, there is no record that the test kits...

2010-04-28 10:42:00

MOUNTAIN VIEW, Calif., April 28 /PRNewswire/ -- Xlumena, a privately held provider of innovative technology for gastroenterologists/interventional endoscopists, today announced it has received clearance from the US Food and Drug Administration (FDA) to market its NAVIX(TM) Access Device. The NAVIX(TM) Device is an advanced endoscopy system, consisting of a multi-lumen catheter with a trocar, anchor and dilation balloons and two guidewire ports, designed to enable secure access, dilation...


Word of the Day
mallemaroking
  • Nautical, the visiting and carousing of sailors in the Greenland ships.
This word is apparently from a confusion of two similar Dutch words: 'mallemerok,' a foolish woman, and 'mallemok,' a name for some persons among the crew of a whaling vessel.