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Applied Genetic Technologies' gene therapy product receives E.U. orphan drug designation

Oct. 26, 2015

Hemispherx's MERS product receives positive opinion for E.U. orphan designation

Oct. 26, 2015

Genvoya noninferior to Stribild in phase III studies in treatment-naive adults with HIV infection

Oct. 23, 2015

EMA adopts positive opinion on new orphan designations for KTE-C19

Oct. 16, 2015

CF-102 receives EMA orphan drug designation for HCC

Oct. 13, 2015

Akebia reaches agreement with FDA and EMA on phase III program for vadadustat

Oct. 7, 2015

EMA accepts Ultragenyx's MAA for aceneuramic acid prolonged release

Oct. 5, 2015

PTC Therapeutics submits variation for new indication in Europe for Translarna

Oct. 1, 2015

EMA committee recommends approval of Numient for Parkinson's disease

Sep. 29, 2015

European committee recommends approval of aflibercept for myopic CNV

Sep. 28, 2015

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