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

EMA
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CHMP recommends European approval of once-weekly somatropin

June 3, 2013

CMDh endorses EMA committee's recommendation on benefit/risk profile of Diane-35

June 3, 2013

European CHMP recommends approval of Lojuxta

June 3, 2013

European CHMP recommends approval of pomalidomide for rrMM

June 3, 2013

BioMarin's applications for Vimizim accepted by both FDA and EMA

May 31, 2013

EMA grants orphan drug designation to Sucampo's retinitis pigmentosa therapeutic

May 30, 2013

EMA grants accelerated assessment to Gilead's MAA for sofosbuvir

May 22, 2013

EMA's CHMP recommends restricting use of Protelos/Osseor

April 29, 2013

European CHMP recommends conditional approval of Erivedge for BCC

April 29, 2013

CHMP issues positive opinion for approval of Nuedexta

April 29, 2013
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