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BioWorld - Saturday, February 21, 2026
Home » Topics » Regulatory » EMA

EMA
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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

EMA accepts for review MAA for adalimumab biosimilar SB-5

July 18, 2016

EMA committee recommends orphan drug designation for Akari's Coversin

July 13, 2016

EMA's review of conditional MAA for masitinib to follow standard timeline

July 5, 2016

EMA grants an expansion to orphan drug designation for ATIR-101

July 5, 2016

EMA committee recommends granting orphan drug designation to Vicore's C-21 in IPF

June 29, 2016

EMA recommends approval of Keytruda for advanced NSCLC

June 28, 2016

Puma submits MAA to the EMA for neratinib

June 28, 2016
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