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BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA accepts Tagrisso submission in first-line EGFR-mutated NSCLC

Nov. 28, 2017

EMA accepts Macrilen MAA for adult growth hormone deficiency

Nov. 28, 2017

EMA launches improved version of EudraVigilance system for safety monitoring

Nov. 22, 2017

EMA announces relocation to the Netherlands

Nov. 21, 2017

Orexo's Zubsolv approved for opioid dependence in Europe

Nov. 21, 2017

bb-2121 receives FDA breakthrough therapy and EMA PRIME designations

Nov. 17, 2017

Marketing applications for volanesorsen accepted in U.S., E.U. and Canada

Nov. 16, 2017

EMA grants Motrem access to PRIME scheme for septic shock

Nov. 15, 2017

EMA's CHMP issues positive opinion on Adcetris for CTCL

Nov. 15, 2017

EMA committee supports approval of Endoceutics' Intrarosa

Nov. 15, 2017
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