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March 27, 2014
07:08 EDTALIM, PSDVpSivida announces resubmission of NDA for ILUVIEN
pSivida Corp. (PSDV) announced that the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema has been resubmitted to the U.S. Food and Drug Administration. In the resubmission, pSividas licensee, Alimera Sciences (ALIM), responded to questions raised in the FDAs October 2013 complete response letter and provided a safety update, which included commercial experience with ILUVIEN in Europe. Alimera is awaiting the FDAs acceptance of the resubmission and a Prescription Drug User Fee Act date. pSivida will report that information when it becomes available.
News For PSDV;ALIM From The Last 14 Days
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November 17, 2014
11:50 EDTPSDVpSivida reports ILUVIEN granted marketing authorization in Ireland
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11:46 EDTALIMAlimera Sciences' ILUVIEN receives marketing approval in Ireland
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10:02 EDTALIMOn The Fly: Analyst Initiation Summary
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08:55 EDTALIMAlimera Sciences initiated with a Buy at Summer Street
Target $12.
November 12, 2014
07:43 EDTALIMAlimera Sciences' Iluvien receives marketing authorization in Belgium
Alimera Sciences,announced that the Belgian Federal Agency for Medicines and Health Products has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Approval in Belgium marks the fourth European approval through the Repeat-Use application procedure and the 12th approval worldwide, including the recent U.S. approval for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. To date, ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany. ILUVIEN is pending approval in an additional six European Union countries included in the Repeat-Use application procedure. These countries are the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.
07:34 EDTPSDVpSivida granted marketing authorization for ILUVIEN in Belgium
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