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Biotech / Medical : Incyte (INCY)
INCY 104.09-1.3%Nov 14 9:30 AM EST
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To: scaram(o)uche who wrote (2747)11/6/2012 4:19:17 PM
From: scaram(o)uche  Read Replies (2) of 3202
 
Tofacitinib approved.

fda.gov

The FDA approved Xeljanz with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide advising patients about important safety information and a communication plan to inform health care providers about the serious risks associated with Xeljanz.
To study the long-term effects of Xeljanz on heart disease, cancer, and serious infections, the FDA is requiring a postmarketing study that will evaluate two doses of Xeljanz and include a group of patients on another approved treatment to serve as a comparison.
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