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FzioMed aims for year-end U.S. approval

By   /  Friday, June 20th, 2014  /  Central Coast, Law, Technology, Tri-County Economy  /  Comments Off on FzioMed aims for year-end U.S. approval

After nearly eight years of tangling with the Food and Drug Administration, San Luis Obipso-based FzioMed said it might receive approval to sell its products in the U.S. by year’s end.

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Vapor Hub hopes to lead the way in $3B e-cigarette market

By   /  Friday, May 9th, 2014  /  East Ventura County, Top Stories, Tri-County Economy, Tri-County Public Companies  /  Comments Off on Vapor Hub hopes to lead the way in $3B e-cigarette market

With the U.S. Food and Drug Administration promising to impose regulations on the free-for-all e-cigarette market, Simi Valley-based Vapor Hub International is hoping to help the industry grow up.

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Amgen braces for biosimilars rules

By   /  Friday, October 7th, 2011  /  Banking & Finance, Technology, Top Stories, Tri-County Public Companies  /  Comments Off on Amgen braces for biosimilars rules

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Amgen expects approval for Xgeva as bone treatment in April

By   /  Monday, August 22nd, 2011  /  Banking & Finance, Latest news, Technology, Tri-County Public Companies  /  Comments Off on Amgen expects approval for Xgeva as bone treatment in April

Thousand Oaks-based Amgen said Aug. 22 that the U.S. Food and Drug Administration will likely make a decision by April 26, 2012 on the biotech firm’s application to expand the use of its Xgeva bone treatment drug to treat advanced prostate cancer. Amgen, the largest biotech company in the world, said in a statement that Read More →

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Amgen gets sought-after FDA approval

By   /  Thursday, November 18th, 2010  /  Latest news, Technology, Tri-County Public Companies  /  Comments Off on Amgen gets sought-after FDA approval

The Food and Drug Administration has approved the use of Amgen’s bone drug denosumab in patients with certain types of cancer, Amgen announced Nov. 18.

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FDA OKs Aranesp for pre-dialysis patients

By   /  Monday, October 25th, 2010  /  Latest news, Technology  /  Comments Off on FDA OKs Aranesp for pre-dialysis patients

Amgen’s anemia treatment Aranesp is safe for kidney patients whose disease doesn’t require dialysis, a federal panel announced Oct. 18 in response to a study that found the drug could increase stroke risk in those patients. Outside advisers to the U.S. Food and Drug Administration said the treatment shouldn’t be withdrawn or limited to a Read More →

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