Galapagos receives positive CHMP opinion for Jyseleca® European label update based on testicular function safety data from MANTA/RAy studies

Posted: October 4, 2022 at 2:33 am

Type II variation1 regulatory application to amend the European label of Jyseleca® (filgotinib) based on data from MANTA and MANTA-RAy studies in patients with inflammatory bowel disease (IBD) and rheumatic conditions (RC) respectively

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Galapagos receives positive CHMP opinion for Jyseleca® European label update based on testicular function safety data from MANTA/RAy studies

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