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News Breaks | | | | February 8, 2013 | | 15:37 EDT |  | CELG, ONXX | FDA announces approval of Celgene multiple myeloma treatment The FDA said it approved Celgene's (CELG) Pomalyst to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. In July 2012, the FDA approved Kyprolis to treat multiple myeloma. The FDA said that similar to Onyx Pharmaceuticals' (ONXX) Kyprolis, Pomalyst is being approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use. The therapy was also granted orphan product designation because it is intended to treat a rare disease or condition. Pomalyst carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and that the drug can cause blood clots. Because of Pomalyst’s embryo-fetal risk, it is available only through the Pomalyst Risk Evaluation and Mitigation Strategy Program. | |
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News For CELG;ONXX From The Last 14 Days Check below for free stories on CELG;ONXX the last two weeks. |
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| May 24, 2013 | | 07:20 EDT |  | CELG | Celgene, Gilead, and Biogen could go much higher, says Bernstein
Subscribe for More Information | | | May 23, 2013 | | 07:37 EDT |  | CELG | Celgene says FDA grants priority review for ABRAXANE sNDA
Subscribe for More Information | | | May 21, 2013 | | 13:36 EDT |  | ONXX | Onyx Pharmaceuticals mentioned cautiously at BofA/Merrill
Subscribe for More Information | | | May 20, 2013 | | 09:51 EDT |  | CELG | Celgene management to meet with JPMorgan Meetings to be held in Boston on May 22-23 hosted by JPMorgan. | | | May 17, 2013 | | 05:51 EDT |  | CELG | Stocks with implied volatility movement; CBST CELG
Subscribe for More Information | | | May 16, 2013 | | 11:50 EDT |  | CELG | Celgene, Gilead lower after new data published at ASCO
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