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  1. UPDATE 1- FDA raises concerns about Impax's Taiwanese plant

    Headlines

    Tue, 29 Jul 2014

    July 29 (Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued certain observations regarding violations in the company's manufacturing plant in Taiwan.

  2. FDA approves Sorin heart valve

    Headlines

    Tue, 29 Jul 2014

    The FDA clears Sorin Group's ( OTC:SORJF ) Solo Smart Aortic Pericardial Heart Valve. It is the first valve with a removable stent approved in the U.S. The product is designed from bovine pericardium. Post your comment!

  3. Masimo debuts wireless patient monitor in Europe

    Headlines

    Tue, 29 Jul 2014

    Masimo's (NASDAQ: MASI ) Radius-7 wireless patient monitor receives CE Mark clearance in Europe. The company is proceeding with a limited market release of the product. It has not yet been cleared by the FDA . Post your comment!

  4. Biogen: The Pioneer In The Hemophilia A Market

    Headlines

    Tue, 29 Jul 2014

    drug , Eloctate, for the treatment of Hemophilia A in the United States for both adults and children. Biogen also received the FDA approval for its Hemophilia B's therapy, Alprolix, a few months ago. Let's take a look at the prevailing market of Hemophilia

  5. U.S. FDA raises concerns about Impax's Taiwanese plant

    Headlines

    Tue, 29 Jul 2014

    July 29 (Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued "certain observations" after an inspection of the company's manufacturing plant in Taiwan.

  6. FDA clears Arrow catheter

    Headlines

    Tue, 29 Jul 2014

    The FDA grants 510(k) clearance to Teleflex (NYSE: TFX ) subsidiary Hotspur Technologies' Arrow GPSCath Balloon Dilation Catheter

  7. Guided Therapeutics files LuViva PMA amendment

    Headlines

    Mon, 28 Jul 2014

    In response to the FDA 's September 6, 2013 not-approvable letter, Guided Therapeutics ( OTCQB:GTHP +0.8% ) files an amendment to its PMA application

  8. The Product Development Story Of Provectus Biopharmaceuticals

    Headlines

    Mon, 28 Jul 2014

    By M Plaut : When Provectus Biopharmaceuticals Inc. (NYSEMKT: PVCT ) announced at the end of May that the FDA had denied it Breakthrough Therapy Designation (BTD) it caused a sharp drop in the stock price. The extreme move in the stock

  9. EDAP tanks as Ad Comm meeting approaches

    Headlines

    Mon, 28 Jul 2014

    Shares of EDAP TMS S.A. ( EDAP -21.5% ) drop on a 3x surge in volume. Earlier today, the FDA released its briefing documents for Wednesday's meeting of the Gastroenterology and Urology Devices Panel. The Committee will

  10. MannKind: Let It Dip A Bit More, Then Cover/Buy

    Headlines

    Mon, 28 Jul 2014

    might find MannKind's (NASDAQ: MNKD ) FDA approval as a good time to short the stock ..... MannKind bulls didn't seem to think that an FDA approval would go through without a partnership ..... success immediately after their drug's FDA approval. I also made the point that a

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