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News Breaks
May 5, 2014
06:33 EDTALXNAlexion's Soliris approved by FDA from accelerated to regular approval
Alexionís supplemental Biologics License Application providing regular approval for Soliris for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy has been approved by the FDA. This update reflects Alexionís fulfillment of post-marketing requirements, including the submission of confirmatory data from two additional prospective clinical trials, including one in pediatric patients with aHUS. The revised label now specifies important longer-term clinical benefit associated with chronic and sustained Soliris treatment with inclusion of results with two years of ongoing treatment in aHUS patients. The updated label also includes data on the use of Soliris treatment prior to use of supportive care with either plasma exchange or plasma in prospective clinical trials.
News For ALXN From The Last 14 Days
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October 20, 2014
07:19 EDTALXNIBC Life Sciences to hold a conference
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07:10 EDTALXNAmerican Society of Human Genetics to hold annual meeting
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October 15, 2014
06:35 EDTALXNAlexion submits NDA in Japan for treatment of hypophosphatasia
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October 9, 2014
10:41 EDTALXNHigh option volume stocks
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06:36 EDTALXNAlexion appoints new chairman and creates Lead Independent Director position
Alexion has appointed Leonard Bell, M.D. as Chairman of the Board of Directors. Dr. Bell, principal founder of Alexion, continues to serve as CEO. Additionally, R. Douglas Norby has been appointed to the newly created Board position of Lead Independent Director. Mr. Norby has been a Director of Alexion since September 1999. Both of these appointments follow the passing of Max Link, Ph.D., who served as the Chairman of the Board of Directors of Alexion since December 2002 and as a member of the Board since the companyís inception in 1992.

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