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BioWorld - Monday, July 27, 2026
Home » Topics » Regulatory » EMA

EMA
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EC grants orphan status to pralatrexate for cutaneous T-cell lymphoma

June 21, 2010

OBI-1 obtains positive opinion for orphan drug status in Europe

June 18, 2010

EMA approves update to bortezomib label for multiple myeloma

June 17, 2010

COMP recommends orphan drug status for 2B3-101 in glioma

June 16, 2010

EMA's COMP recommends orphan status for DR Cysteamine in cystinosis

June 16, 2010

European Commission extends indication of RoActemra

June 10, 2010

Sunesis receives scientific advice from EMA on voreloxin program

June 3, 2010

EMA considers postapproval commitment fulfilled for Ceplene/IL-2 in AML

June 2, 2010

Wyeth Europa notifies EMA of withdrawal of MAA for Brilence

June 1, 2010

FDA and EMA approve reanalysis of images from phase III RG-1068 trial

May 31, 2010
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