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CHMP recommends 10 new medicines for approval in the EU
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New recommendations to ensure these medicines reach those who need them most
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Revised transparency rules for Clinical Trials Information System (CTIS) have become applicable
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Board adopts Executive Director’s 2023 annual activity report and is updated on new fee regulation
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New appointments in the Legal Department and the Regulatory Science and Innovation Task Force
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10 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
Winrevair received support through PRIority Medicines (PRIME) scheme due to its potential to bring a major therapeutic advantage over existing therapies
Eurneffy (epinephrine) is an alternative to injectable formulations
Benefits of Ocaliva no longer considered to outweigh its risks
Opinion follows review of additional data and advice from group of experts.