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BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory » EMA

EMA
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LMS-611 obtains European orphan drug status in cystic fibrosis

June 21, 2011

French and German authorities suspend use of pioglitazone-containing products

June 14, 2011

COMP issues opinion on orphan drug of CYT-387 in myelofibrosis

June 2, 2011

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
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