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BioWorld - Friday, January 16, 2026
Home » Topics » Regulatory » EMA

EMA
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CHMP recommends extended indication for Rebif in patients with early signs of MS

Nov. 21, 2011

Starpharma reaches agreement with EMA on phase III program for VivaGel

Nov. 21, 2011

AstraZeneca receives positive CHMP opinion for vandetanib

Nov. 21, 2011

EMA accepts Nuedexta MAA for filing

Nov. 18, 2011

AMT's gene therapy for hemophilia B given orphan drug status in Europe

Nov. 16, 2011

FDA and EMA accept Astellas' submissions for mirabegron

Nov. 15, 2011

Merck Sharp & Dohme withdraws MAA for fixed-dose combination of sitagliptin and pioglitazone

Nov. 15, 2011

EC withdraws marketing authorization for Ablavar

Nov. 14, 2011

Novartis presents key developments of third quarter 2011

Nov. 11, 2011

Discovery Labs' lucinactant gains European orphan drug status

Nov. 4, 2011
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