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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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May 28, 2015
10:12 EDTALXNHigh option volume stocks
High option volume stocks: A RS ALXN AVGO TFM PLKI JNPR VGK GDOT
07:25 EDTALXNEuro Renal Association / Euro Dialysis & Transplant Assoc to hold conference
52nd ERA-EDTA Congress is being held in London, England on May 28-31.
May 15, 2015
07:47 EDTALXNAlexion risk/reward profile favorable, says Barclays
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