CHMP

News

Novo Nordisk's Rybelsus has become the first oral GLP-1 agonist to pick up a regulatory approval for cardiovascular risk reduction.

News

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.

News

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

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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.

News

Italfarmaco's oral HDAC inhibitor Duvyzat has been recommended for approval in the EU as a treatment for Duchenne muscular dystrophy (DMD).

News

The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug.