Uterine Fibroids

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval for ObsEva SA's (NASDAQ: OBSV) linzagolix, an oral GnRH antagonist to manage moderate to severe symptoms of uterine fibroids. If...

The FDA has accepted for review ObsEva SA's (NASDAQ: OBSV) marketing application for linzagolix to manage heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The submission is based on data from the two Phase 3 PRIMROSE trials.  The FDA set a...

ObsEva SA (NASDAQ: OBSV) has announced data from PRIMROSE (1 and 2) Phase 3 study of linzagolix for uterine fibroids. The data were presented at the American Society for Reproductive Medicine (ASRM) 2021 Scientific Congress & Expo. Related: ObsEva Files US Application For...

ObsEva SA (NASDAQ: OBSV) has submitted a marketing application to the FDA seeking approval for linzagolix for uterine fibroids.  Linzagolix is an oral GnRH receptor antagonist.  Related Link: ObsEva Shares Gains On Positive Linzagolix Data In Uterine Fibroids Study. The Company...

The European Commission (EC) has approved Myovant Sciences Ltd's (NYSE: MYOV) Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women. The approval is based on safety and...

The FDA has approved Myovant Sciences Ltd (NYSE: MYOV) and Pfizer Inc’s (NYSE: PFE) relugolix combined with estradiol and norethindrone acetate for heavy menstrual bleeding linked to uterine fibroids in premenopausal women. The once-daily treatment will be marketed...

European Medicines Agency's advisory committee issued a positive opinion recommending the approval of Myovant Sciences Ltd's (NYSE: MYOV) Ryeqo (relugolix, estradiol, and norethindrone acetate) for uterine fibroids. The final decision on the application is expected to...

ObsEva SA (NASDAQ: OBSV) has announced final 76-week results from the PRIMROSE 1 Phase 3 clinical study evaluating Yselty (linzagolix) for heavy menstrual bleeding due to uterine fibroids. These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 (US only)...