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BioWorld - Tuesday, May 5, 2026
Home » Topics » Regulatory » EMA

EMA
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Regorafenib recommended for approval in Europe for GIST

June 30, 2014

Vertex receives positive CHMP opinion to expand Kalydeco approval

June 30, 2014

EMA accepts Ravicti MAA

June 26, 2014

EMA's COMP adopts positive opinion on marizomib in multiple myeloma

June 25, 2014

FDA and EMA accept applications for AbbVie's HCV regimen

June 17, 2014

European orphan drug designation awarded to Betalutin for follicular lymphoma

June 12, 2014

EMA validates MAA for Raxone in Leber's hereditary optic neuropathy

June 6, 2014

EMA grants accelerated assessment to nintedanib MAA for IPF

June 5, 2014

EMA accepts Hetlioz MAA for review

June 4, 2014

EMA's CHMP confirms negative opinion for RLX-030

May 27, 2014
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