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BioWorld - Monday, June 15, 2026
Home » Topics » Regulatory » EMA

EMA
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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

EMA CHMP gives positive opinion on ZS-9 for hyperkalemia

Feb. 27, 2017

EMA committee supports conditional marketing approval for Shire's Natpar

Feb. 27, 2017

EMA grants orphan drug designation to LYS-GM101 for the treatment of GM1 gangliosidosis

Feb. 22, 2017

Armetheon receives advice from EMA on pivotal study of oral anticoagulant

Feb. 15, 2017
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