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BioWorld - Wednesday, December 24, 2025
Home » Topics » Regulatory » EMA

EMA
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Genta receives EMA advice for phase III tesetaxel trial in gastric cancer

Nov. 3, 2010

E.U. grants authorization for Ruconest in hereditary angioedema

Oct. 29, 2010

EMA recommends changes in prescribing information for Invirase

Oct. 26, 2010

CHMP recommends new indication for Bristol-Myers Squibb's Sprycel

Oct. 26, 2010

CHMP recommends variation of marketing authorization for Pfizer's Sutent

Oct. 26, 2010

CHMP recommends marketing authorization for MedImmune's FluEnz vaccine

Oct. 26, 2010

CHMP issues positive opinion on ranibizumab for DME-related vision impairment

Oct. 25, 2010

EMA initiates review of Orion's centralized MAA for dexmedetomidine

Oct. 22, 2010

EC grants orphan drug status for nafamostat mesilate in cystic fibrosis

Oct. 21, 2010

Roche files to extend indication of tocilizumab for systemic juvenile idiopathic arthritis

Oct. 21, 2010
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