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BioWorld - Tuesday, April 14, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA to review Gentium's MAA for defibrotide under accelerated assessment

June 2, 2011

EMA accepts Pfizer's regulatory filing for axitinib in renal cell carcinoma

June 2, 2011

EMA and Health Canada recommend revaccination with Ixiaro vaccine due to batch recall

May 30, 2011

EMA accepts for review Savient Pharmaceuticals' MAA for Krystexxa

May 30, 2011

NeuroSearch to conduct phase III confirmatory trial of Huntexil

May 26, 2011

CHMP issues negative trend vote on Bronchitol for cystic fibrosis

May 25, 2011

EMA's CHMP recommends label extension for tocilizumab

May 24, 2011

EMA committee recommends accelerated approval of Victrelis for hepatitis C genotype 1

May 23, 2011

CHMP recommends approval of Vibativ for nosocomial pneumonia caused by MRSA

May 23, 2011

GSK and Human Genome Sciences receive CHMP positive opinion for Benlysta

May 23, 2011
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