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BioWorld - Tuesday, April 21, 2026
Home » Topics » Regulatory » EMA

EMA
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NTP-42 receives E.U., U.S. orphan designations for pulmonary arterial hypertension

March 8, 2018

Vocimagene amiretrorepvec/5-fluorocytosine granted E.U. orphan designation for glioma

March 8, 2018

EMA accepts regulatory submission for Forxiga in adults with type 1 diabetes

March 7, 2018

Gene therapy from Meiragtx receives European PRIME disgnation

March 5, 2018

EMA grants orphan drug designation to MTD-119 for hepatocellular carcinoma

March 1, 2018

EMA gives accelerated assessment to Shire's lanadelumab

Feb. 28, 2018

EMA grants orphan drug designation to cannabidiol for tuberous sclerosis

Feb. 28, 2018

EMA committee recommends change to marketing authorization terms for Feraccru

Feb. 26, 2018

BioCryst's Alpivab recommended for approval in E.U. for uncomplicated influenza

Feb. 26, 2018

Amglidia recommended for E.U. approval for neonatal diabetes

Feb. 26, 2018
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