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BioWorld - Friday, February 13, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA CHMP recommends approval of Sandoz adalimumab biosimilar

June 4, 2018

Aimovig receives positive CHMP opinion for the prevention of migraine

June 4, 2018

Exondys receives negative CHMP opinion

June 4, 2018

Tegsedi receives positive opinion in Europe

June 4, 2018

EMA validates MAA for Inbrija

May 30, 2018

EMA accepts European filing for edaravone for ALS

May 29, 2018

European designation decisions for BioCryst's BCX-7353 for HAE

May 25, 2018

EMA approves Lynparza tablets for the treatment of platinum-sensitive relapsed ovarian cancer

May 9, 2018

EMA gives positive scientific advice on development plan and regulatory pathway for AM-111

May 8, 2018

EMA validates type II variation application for Opdivo plus Yervoy in first-line NSCLC

May 4, 2018
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