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BioWorld - Sunday, June 14, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA approves pediatric investigation plan for TiGenix's Cx-601

Sep. 9, 2014

European orphan drug designations for CER-001 in apoA-I and ABCA1 deficiencies

Sep. 3, 2014

ALN-AT3 receives orphan drug designations in the E.U.

Aug. 8, 2014

NeuroDerm's ND-0612H eligible for EMA's centralized procedure

Aug. 7, 2014

U.S. and E.U. orphan drug designations for AbbVie's ABT-414 for glioblastoma multiforme

Aug. 5, 2014

Intravenous posaconazole recommended for approval in E.U.

Aug. 1, 2014

EMA accepts Eisai's request for accelerated assessment of lenvatinib

Aug. 1, 2014

EMA committee recommends approval of Baraclude for pediatric patients with HBV

July 30, 2014

Novo Nordisk receives positive CHMP opinion on Xultophy

July 29, 2014

CHMP recommends extension of Ozurdex indication in diabetic macular edema

July 28, 2014
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