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BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory » EMA

EMA
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CHMP grants positive opinion for labeling update to Relvar Ellipta in patients with asthma

Jan. 29, 2018

EMA accepts patisiran MAA for hereditary ATTR amyloidosis

Jan. 26, 2018

Santhera anticipates negative CHMP opinion on appeal for MAA for Raxone

Jan. 25, 2018

U.S. priority review and E.U. accelerated assessment granted for Kymriah

Jan. 17, 2018

EMA accepts Evenity MAA in osteoporosis

Jan. 8, 2018

EMA gives orphan drug designation to Spruce Biosciences' SPR-001

Jan. 8, 2018

EMA accepts CMA application for avacopan for ANCA-associated vasculitis

Jan. 4, 2018

Cascadian Therapeutics receives pediatric investigation plan waiver from EMA for tucatinib

Jan. 3, 2018

BiondVax Pharmaceuticals planning phase III study of universal flu vaccine

Dec. 29, 2017

EMA committee recommends against approval of Aplidin for multiple myeloma.

Dec. 19, 2017
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