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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

EMA gives Provenge a positive opinion

July 3, 2013

CHMP issues positive opinion on two variations for Velcade

July 2, 2013

Regorafenib recommended for approval in the E.U.

July 2, 2013

European CHMP recommends approval of two infliximab biosimilars

July 2, 2013

EMA recommends approval of two GSK cancer drugs

July 2, 2013

Approval of Lemtrada for relapsing remitting MS recommended in Europe

July 2, 2013

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