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.
Read More →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.
Read More →Amgen braces for biosimilars rules
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Read More →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 →
Read More →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.
Read More →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 Outside advisers to the U.S. Food and Drug Administration said the treatment shouldn’t be withdrawn or limited to a Read More →
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