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BioWorld - Saturday, December 20, 2025
Home » Topics » Regulatory » EMA

EMA
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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

Prolia obtains marketing authorization in E.U.

May 31, 2010

Vaxon's Vx-001 to advance from phase I/II to phase III in NSCLC

May 21, 2010

EMA issues positive opinion for orphan status of AEZS-108 in ovarian cancer

May 19, 2010

CHMP adopts positive opinion for variation to terms of Reyataz marketing authorization

April 28, 2010
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