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BioWorld - Wednesday, April 29, 2026
Home » Topics » Regulatory » EMA

EMA
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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

EMA's CHMP grants positive opinion to Cabometyx in RCC

July 25, 2016

EMA committee recommends approval of Onivyde in E.U.

July 25, 2016

EMA proposes changes to guidance on first-in-human trials

July 22, 2016

EMA grants orphan drug designation to XOMA-358

July 21, 2016

Cynapsus Therapeutics reaches agreement with the EMA for APL-130277 development

July 20, 2016

The EMA classifies AXAL as advanced therapy medicinal product

July 19, 2016

Cladribine tablet MAA accepted for review by EMA

July 18, 2016
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