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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

Amgen's Kyprolis and Blincyto receive positive opinions from EMA's CHMP

Sep. 28, 2015

EMA committee hands down positive opinion for Ravicti

Sep. 28, 2015

Exelixis' cobimetinib receives positive opinion from CHMP for treatment of melanoma

Sep. 28, 2015

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