FDA to Review Data on Long-Term Use of Myfembree for Uterine Fibroids
The study enrolled women who completed the 24-week LIBERTY 1 and 2 studies and the 28-week open-label extension studies, and who met the definition of a responder.
Dysmenorrhea
Beyond Hysterectomy: Increasing Awareness of Uterine Fibroids and New Treatment Options
Interview with Andrea Lukes, MD, MHSc, FACOG, board certified obstetrician/gynecologist and found and CEO of the Carolina Women’s Research and Wellness Center.
FDA Extends Review Period for Relugolix Combo Therapy for Endometriosis Pain
The FDA extended the action date to review additional information regarding bone mineral density.
Linzagolix Under Review for Treatment of Uterine Fibroids
Linzagolix is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist.
Linzagolix NDA Submitted for Uterine Fibroid Treatment
The NDA submission is supported by data from the phase 3 PRIMROSE 1 and PRIMROSE 2 studies, along with data from the 76-week post-treatment follow-up study.
FDA to Review Relugolix Combination Therapy for Endometriosis Pain
The application is supported by data from the phase 3 SPIRIT program, which includes the SPIRIT 1 and SPIRIT 2 studies, as well as an open-label extension study.
Myfembree Now Available for Heavy Menstrual Bleeding With Uterine Fibroids
Myfembree consists of relugolix, a gonadotropin-releasing hormone receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.
Myfembree Approved for Heavy Menstrual Bleeding With Uterine Fibroids
Myfembree is a combination of relugolix, a gonadotropin-releasing hormone receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.
Consistent Benefits Seen With Linzagolix in Uterine Fibroids Trial
At 76 weeks, results showed that off-treatment pain scores remained lower than baseline across all linzagolix treatment arms.
FDA to Review Relugolix Combination Therapy for Uterine Fibroids
The NDA submission is supported by results from the phase 3 LIBERTY program.
