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News: EMA recommends eight new medicines, refuses one

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The European Medicines Agency (EMA) has recommended 8 new medications which are yet to be approved while citing a negative opinion over an anti-tumor drug. The committee recommended conditional marketing authorization for Gilead’s Veklury (remdesivir) for the treatment of COVID-19 in those 12 years and older requiring supplemental oxygen.

The human medicines committee (CHMP) of EMA recommended refusal of the marketing authorization for Daiichi Sankyo’s Turalio (pexidartinib), which was to be used to treat tenosynovial giant cell tumors. The agency cited concern for a small improvement in clinical outcomes and uncertainty about the duration of effect.