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BioWorld - Tuesday, April 14, 2026
Home » Topics » Regulatory » EMA

EMA
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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

Aimovig receives positive CHMP opinion for the prevention of migraine

June 4, 2018

Exondys receives negative CHMP opinion

June 4, 2018

Tegsedi receives positive opinion in Europe

June 4, 2018
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