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BioWorld - Saturday, June 13, 2026
Home » Topics » Regulatory » EMA

EMA
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Xilonix will undergo accelerated assessment in E.U.

April 4, 2016

CHMP recommends approval of Strimvelis for ADA-SCID

April 4, 2016

Samsung Bioepis' infliximab biosimilar receives positive opinion in E.U.

April 4, 2016

EMA's CHMP backs approval of Trevicta for schizophrenia

April 4, 2016

Amicus' migalastat gets positive opinion from EMA for Fabry disease

April 4, 2016

EMA's COMP backs orphan drug designation for CDNF in ALS

March 31, 2016

Coagadex receives approval in Europe

March 31, 2016

Ubenimex awarded orphan drug designation in E.U. for PAH

March 29, 2016

EMA approves centralized review of Pulmaquin

March 18, 2016

Regulatory agencies review Zydelig over serious adverse events in ongoing trials

March 16, 2016
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