The stage has been set for approval of the first chimeric antigen T-cell therapies (CAR-T) in Europe, after Novartis’ Kymriah and Gilead’s Yescarta both won backing from the Committee for Medicinal Products for Human Use (CHMP).
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Doctors are not to prescribe Gedeon Richter’s Esmya for uterine fibroids in the UK while European regulators carry out a safety review of the drug.
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Allergan and Gedeon Richter are gearing up to file ulipristal acetate in the US in the second half of this year, in the hope of securing approval for the first oral treatment option for women suffering from uterine fibroids in the country.
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