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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

EMA validates Sarepta's MAA for eteplirsen in Duchenne muscular dystrophy

Dec. 20, 2016

CHMP grants positive opinion for Alecensa for the treatment of NSCLC

Dec. 20, 2016

CHMP grants positive opinion to acknowledge that Jardiance reduces the risk of CV death

Dec. 20, 2016

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