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BioWorld - Monday, May 11, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA grants positive opinion for orphan drug status for enadenotucirev

Jan. 14, 2015

EMA accepts alirocumab MAA for review

Jan. 12, 2015

Celgene receives positive CHMP opinion to extend Revlimid indication

Dec. 24, 2014

EMA committee recommends approval of dalbavancin

Dec. 24, 2014

Xiapex receives positive opinion by CHMP for Peyronie's disease

Dec. 23, 2014

CHMP backs approval of Orexigen's naltrexone/bupropion for weight management

Dec. 22, 2014

EMA committee recommends approval of Xadago to treat mid- to late-stage Parkinson's disease

Dec. 22, 2014

Polaris' ADI-PEG20 receives E.U. orphan drug status for MPM

Dec. 22, 2014

CCX-168 receives European orphan designation for ANCA-associated vasculitis

Dec. 9, 2014

EMA determines no evidence that Fluad caused deaths in Italy

Dec. 9, 2014
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