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The EMA’s PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
Allergan announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ulipristal acetate (UPA) for the treatment of abnormal uterine bleeding in women with uterin
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).