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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

EMA grants BioMarin's BMN-270 for hemophilia A access to PRIME initiative

Feb. 2, 2017

EMA accepts peramivir MAA from BioCryst

Jan. 31, 2017

Amgen receives positive opinion for biosimilar adalimumab ABP-501

Jan. 30, 2017

EMA committee gives positive opinion for Pfizer's Xeljanz

Jan. 30, 2017

EMA's CHMP supports approval of Revlimid for post-ASCT maintenance therapy in MM

Jan. 30, 2017

EMA grants accelerated assessment to glecaprevir/pibrentasvir MAA

Jan. 25, 2017

European orphan drug designation for Therabron's CG-367 for bronchiolitis obliterans syndrome

Jan. 24, 2017

Gilead Sciences' MAA for sofosbuvir/velpatasvir/voxilaprevir validated by EMA

Jan. 23, 2017

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