ACOG Develops Consensus on Medical Menstrual Suppression
Guidance emphasizes role of hormonal therapy and should be accompanied by counseling, including discussions of effectiveness of therapy
Diagnosis & Disease Information
Myfembree Approved for Management of Endometriosis Pain
The approval was based on data from the phase 3 SPIRIT program, which included the SPIRIT 1 and 2 studies, as well as the first 28 weeks of an open-label extension study.
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.
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.
