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EMA grants orphan drug designation to AveXis' gene therapy treatment for SMA

June 25, 2015

BioMarin files for European approval of drisapersen for DMD

June 9, 2015

EMA committee adopts positive opinion on pediatric investigation plan for Viaskin Peanut

June 8, 2015

Stempeucel gets E.U. orphan drug designation

June 5, 2015

EMA provides guidance on MAA submission for Locilex

June 4, 2015

EMA validates MAA for emtricitabine/tenofovir alafenamide fumarate for HIV

May 29, 2015

Migalastat granted accelerated assessment by EMA for Fabry disease

May 27, 2015

CHMP recommends approval of Simponi for non-radiographic axial spondyloarthritis

May 26, 2015

Nivolumab receives EMA recommendation for squamous NSCLC

May 25, 2015

Imbruvica recommended for European approval in Waldenstrom's macroglobulinemia

May 25, 2015

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