The FDA has cleared Acessa, from Halt Medical, a new medical system for treating Uterine Fibroids. To ablate targeted fibroids,...
ObsEva SA announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Yselty (linzagolix), an oral GnRH antagonist, for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women (over 18 years of age) of reproductive age.
Myovant Sciences announced the presentation of additional data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorisation for the medicinal product Yselty (linzagolix choline) from ObsEva, intended for the treatment of symptoms of uterine fibroids. Yselty will be available as 100 mg and 200 mg film-coated tablets.
ObsEva announced that the European Commission (EC) has granted marketing authorization for Yselty (linzagolix), an oral GnRH antagonist, for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women (over 18 years of age) of reproductive age.
The National Institute for Health and Care Excellence (NICE) has published guidelines recommending Esmya (ulipristal acetate), a blocker of progesterone,...
ObsEva SA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of linzagolix, an oral GnRH antagonist for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women of reproductive age.
Myovant Sciences and Pfizer Inc. announced that the FDA has approved Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.
The FDA has approved InSightec's next generation Exablate system to treat symptomatic uterine fibroids and changed the labelling to allow...
In a final draft guidance the National Institute for Health and Care Excellence (NICE) has recommended relugolix-estradiol-norethisterone acetate (Ryeqo; Gedeon Ritcher UK) for the treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age.