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BioWorld - Thursday, April 16, 2026
Home » Topics » Regulatory » EMA

EMA
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CHMP issues positive opinion on European orphan drug status for darinaparsin in PTCL

Jan. 21, 2011

Abbott withdraws European MAA for Ozespa

Jan. 19, 2011

ChemGenex notifies EMA of withdrawal of MAA for Tekinex for Ph+ CML

Jan. 17, 2011

New indication for Lucentis in E.U. for vision loss in diabetic macular edema

Jan. 11, 2011

EMA and FDA grant expedited review for boceprevir

Jan. 11, 2011

Invega approved in E.U. for schizoaffective disorder

Jan. 7, 2011

EMA to review Allos' MAA for Folotyn in relapsed or refractory PTCL

Dec. 28, 2010

Novartis receives E.U. approval for Tasigna in newly diagnosed Ph+ CML

Dec. 27, 2010

CHMP recommends marketing authorization for Janssen-Cilag's Xeplion

Dec. 23, 2010

CHMP recommends a variation to marketing terms for Simponi

Dec. 23, 2010
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