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EMA committee recommends Defitelio approval under exceptional circumstances

July 29, 2013

CHMP confirms Xeljanz recommendation

July 26, 2013

FDA and EMA accept Plegridy marketing applications for review

July 22, 2013

EMA grants orphan drug status to OXiGENE's Zybrestat in ovarian cancer

July 19, 2013

EMA committee recommends orphan drug status for Soliris in rare neurological disease

July 19, 2013

Oryzon obtains European orphan drug designation for ORY-1001 in AML

July 17, 2013

FDA and EMA issue decisions regarding C-Path's trial simulation tool for Alzheimer's disease

July 15, 2013

EMA accepts MAA for new insulin glargine biosimilar product

July 9, 2013

EMA approves positive opinion on Omeros' pediatric investigation plan

July 3, 2013

Procysbi receives positive CHMP recommendation

July 3, 2013

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