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News Breaks
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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January 26, 2015
14:07 EDTPSDVpSivida says Finland, Luxembourg granted Iluvien marketing authorization
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14:01 EDTALIMAlimera Sciences' ILUVIEN receives marketing approval in Finland, Luxembourg
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January 14, 2015
11:56 EDTPSDVpSivida reports commencement of ILUVIEN sales in Portugal
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11:49 EDTALIMAlimera Sciences announces first sale of ILUVIEN in Portugal
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