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BioWorld - Sunday, February 15, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA accepts for review brexpiprazole MAA for schizophrenia in adults

March 24, 2017

EMA gives positive scientific advice on approval pathway for Actinium's Iomab-B

March 22, 2017

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
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