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Agreement has been reached on the reform of EU pharma legislation, but industry thinks it does not go far enough to restore the bloc's global status.

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Sanofi is celebrating an approval recommendation in the EU for Teizeild, a first-in-class drug designed to delay the progression of type 1 diabetes.

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Eli Lilly's appeal of a decision by the EMA's human medicines committee not to approve its Alzheimer's disease therapy Kisunla has paid off.

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Madrigal Pharma could be just weeks away from becoming the first drugmaker to claim EU approval for a MASH treatment.

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With new guidance, the EMA is seeking to ramp up the inclusion of pregnant and breastfeeding women in clinical trials.

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The CHMP backed approval of Autolus' leukaemia CAR-T Aucatzyl, as well as drugs from GSK, Roche, SpringWorks, and others, at its May meeting.