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BioWorld - Tuesday, June 16, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA's CHMP recommends conditional approval of Lilly's olaratumab

Sep. 16, 2016

EMA validates Cempra's MAA for solithromycin

Aug. 24, 2016

COMP grants orphan drug designation to AB Science's masitinib in ALS

Aug. 9, 2016

EMA accepts for review MAA for sarilumab

Aug. 1, 2016

Adaptimmune Therapeutics gains access to EMA's PRIME initiative for T-cell therapy

July 29, 2016

Omeros receives scientific advice from EMA on phase III program for OMS-721

July 29, 2016

EMA grants PRIME designation to DNX-2401 for recurrent glioblastoma

July 28, 2016

Ebola Zaire vaccine wins FDA breakthrough therapy designation and PRIME status

July 26, 2016

EMA's CHMP adopts positive opinion on type II variation application for Gilead's Truvada

July 25, 2016

EMA committee supports approval of Eisai's Kisplyx

July 25, 2016
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