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EMA committee agrees on pediatric investigation plan for Macrilen

March 8, 2017

FDA and EMA accept for filing ertugliflozin submissions

March 7, 2017

European Commission approves Ledaga for mycosis fungoides-type CTCL

March 7, 2017

EMA grants orphan drug designation to Resolaris for limb girdle muscular dystrophy

March 6, 2017

EMA grants SPK-9001 access to PRIME program for hemophilia B

March 6, 2017

EMA grants PRIME access to givosiran for acute hepatic porphyrias

March 2, 2017

EMA committee hands down positive opinion for 8-week regimen of Viekirax + Exviera

March 1, 2017

EMA committee hands down positive opinion for Varuby

Feb. 27, 2017

EMA committee recommends broadening approval of Darzalex

Feb. 27, 2017

Tafinlar plus Mekinist granted positive opinion in E.U. for BRAF-positive NSCLC

Feb. 27, 2017

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