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February 8, 2013
15:37 EDTCELG, ONXXFDA 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.
News For CELG;ONXX From The Last 14 Days
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November 22, 2015
13:21 EDTCELGAlphabet, Celgene, others could rise 20% over next year, Barron's says
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November 20, 2015
10:52 EDTCELGFDA approves new oral medication to treat multiple myeloma
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November 17, 2015
08:22 EDTCELGSignificant Celgene overhang removed, says JMP Securities
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November 16, 2015
13:11 EDTCELGCelgene jumps 2% after defeating Kyle Bass patent challenge
Shares of Celgene moved higher after the U.S. Patent and Trademark Office declined to review a Revlimid patent expiring in 2019. The USPTO found that that Bass's Coalition for Affordable Drugs was unlikely to succeed, according to Bloomberg. Shares of Celgene are up 2%, or $1.64, to $190.13 in afternoon trading. The agency is reviewing two other patents on the drug.
13:08 EDTCELGCelgene defeats Bass challenege on Revlimid patent, Bloomberg reports
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