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BioWorld - Monday, May 11, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA grants accelerated assessment to glecaprevir/pibrentasvir MAA

Jan. 25, 2017

European orphan drug designation for Therabron's CG-367 for bronchiolitis obliterans syndrome

Jan. 24, 2017

Gilead Sciences' MAA for sofosbuvir/velpatasvir/voxilaprevir validated by EMA

Jan. 23, 2017

EMA awards orphan designation to Abeona Therapeutics' ABO-101

Jan. 20, 2017

FDA, EMA accept Boehringer Ingelheim's BI-695501 for review

Jan. 19, 2017

EMA accepts for review MAA for KRN-23 in X-linked hypophosphatemia

Jan. 5, 2017

Abeona Therapeutics' ABO-201 granted orphan drug designation in Europe

Jan. 4, 2017

FDA accepts betrixaban NDA for priority review, EMA validates MAA

Dec. 27, 2016

JCAR-017 obtains FDA breakthrough therapy designation and EMA PRIME access

Dec. 21, 2016

CHMP grants positive opinion for Truxima

Dec. 20, 2016
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