The Food And Drug Administration News & Views

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Covidien advances brain aneurysm device External-link
Covidien plc (NYSE: COV) has announced that a study supporting its Pipeline device to treat brain aneurysms has been published in the journal Radiology. The Ireland-based company, with corporate headquarters in Mansfield, Mass., received U.S. Food and Drug Administration approval for the device in April 2011. “Covi...
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Source: Boston Business News -...
Jun 17, 2013 - 9:33 AM
Browse Related Topics:   Mass. U.S. Food A... Mansfield Covidien More    
MannKind Completes Final Inhaler Study External-link
MannKind Corp. said it has completed the second of two additional trials requested by the Food and Drug Administration for its inhaled insulin pipeline product.
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Source: Los Angeles Business J...
Jun 17, 2013 - 8:05 AM
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Can Cempra Beat The Superbugs? External-link
ByC.R. Jackson: "People actually talk these days about a potential return to the "pre-antibiotic era" where we no longer have effective tools to treat serious infectious disease. Clearly, we must encourage more judicious use of these important drugs through improved infection control, rational presc...
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Source: Seeking Alpha
Jun 17, 2013 - 7:37 AM
Browse Related Topics:   Fda U.S. Food A... R &Amp; D R. Jackson More    
Amicus Delays U.S. Approval Filing for Fabry Disease Drug External-link
CRANBURY, NJ (TheStreet) -- The U.S. Food and Drug Administration refused a request from Amicus Therapeutics to amend the statistical plan for a failed phase III study of its experimental Fabry disease drug Amigal. As a result, Amicus is delaying the U.S. approval filing for Amigal until late 2014 or early 2015 -- ...
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Source: The Street
Jun 17, 2013 - 5:43 AM
Browse Related Topics:   U.S. Iii U.S. Food A... Amicus More    
Feds urge medical device makers to brace for cyber attacks External-link
Federal regulators are warning medical device makers to prepare for potential cyber attacks that could threaten their patented products as well as patient safety. According to Reuters, the U.S. Food and Drug Administration issued the advisory June 14 in coordination with the Department of Homeland Security, which d...
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Source: Boston Business News -...
Jun 17, 2013 - 3:18 AM
Browse Related Topics:   Massachusetts U.S. Food A... Department ...
Gloomy Prospects For Medical Device Companies External-link
By Ron Sommer: The medical device industry confronts several challenges that will have long-term implications. Revenue in this industry will not grow as quickly over the next five years and the increasingly strict regulatory environment will remain a significant impediment.The U.S. Food and Drug Administration have...
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Source: Seeking Alpha
Jun 15, 2013 - 11:46 PM
Browse Related Topics:   Iii Complete St... U.S. Food A... Ron Sommer
These 2 Healthcare Stocks Could Win Big With FDA's New 'Breakthrough' Status External-link
By StreetAuthority: By Michael Vodicka The Food and Drug Administration (FDA) made a groundbreaking policy change last year that is having a large impact on the biotech industry and creating a big opportunity for investors.To create a faster path to commercialization for potentially life-saving drugs and medicine...
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Source: Seeking Alpha
Jun 14, 2013 - 9:02 AM
Browse Related Topics:   Fda Healthcare ... Michael Vod...
FDA urges protection of medical devices from cyber threats External-link
(Reuters) - The U.S. Food and Drug Administration on Thursday urged medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats that could compromise the devices or patient privacy.
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Source: Reuters
Jun 13, 2013 - 6:05 PM
Browse Related Topics:   Fda U.S. Food A...
Salix shares surge on FDA news External-link
Shares of Salix Pharmaceuticals got a 5 percent bounce Tuesday on news that a Food and Drug Administration advisory committee would review one of its drugs, potentially leading to an expanded use of that drug. Salix (Nasdaq: SLXP), Raleigh’s largest home-grown drug company, wants approval to expand the treatment us...
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Source: Business News from Sou...
Jun 11, 2013 - 12:02 PM
Browse Related Topics:   Food And Dr... Fda Raleigh Relistor
Ariad begins Phase 2 trial of Iclusig to treat GI tumors External-link
Ariad Pharmaceuticals, Inc. (Nasdaq: ARIA) has launched a Phase 2 trial to test its approved leukemia drug Iclusig as a potential treatment for gastrointestinal stromal tumors (GIST). The Cambridge, Mass-based company’s drug was approved by the U.S. Food and Drug Administration in December 2012. It's approved to tr...
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Source: Boston Business News -...
Jun 11, 2013 - 10:56 AM
Browse Related Topics:   Philadelphia Cambridge Gist U.S. Food A... More    
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