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BioWorld - Thursday, June 18, 2026
Home » Topics » Regulatory » EMA

EMA
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CHMP supports approval of Orkambi and expansion of Kalydeco indications

Sep. 28, 2015

Hemophilia A therapy Elocta recommended for E.U. approval

Sep. 28, 2015

EMA CHMP recommends approval of dabigatran reversal agent idarucizumab

Sep. 28, 2015

EMA CHMP grants accelerated assessment of Janssen's daratumumab for MM

Sep. 25, 2015

EMA recommends approval of mepolizumab for severe refractory eosinophilic asthma

Sep. 25, 2015

EMA committee recommends European approval of Entresto

Sep. 25, 2015

EMA grants orphan drug designation to Stemline's SL-401 for AML

Sep. 14, 2015

European ADAPT SMART initiative launched to improve efficiency in drug development

Sep. 8, 2015

Audentes Therapeutics' AT-001 receives orphan drug designation

Aug. 27, 2015

Filings accepted for afatinib as second-line treatment for squamous cell carcinoma of the lung

Aug. 25, 2015
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