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CHMP adopts positive trend vote recommending the approval of the MAA for neratinib

June 27, 2018

EMA validates Giapreza MAA

June 26, 2018

EMA grants PRIME designation for Themis' Chikungunya vaccine

June 12, 2018

FDA and EMA accepts regulatory submissions of talazoparib for review

June 8, 2018

EMA grants PRIME designation for dilanubicel

June 7, 2018

EMA grants PRIME designation to AT-132 for the treatment of X-linked myotubular myopathy

June 6, 2018

Myalepta receives positive CHMP opinion for generalized and partial lipodystrophy

June 5, 2018

EMA committee backs approval of trastuzumab biosimilar Trazimera

June 4, 2018

EMA committee recommends approval of Translarna for younger children with DMD

June 4, 2018

EMA CHMP recommends approval of Sandoz adalimumab biosimilar

June 4, 2018

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