FDA to Review Relugolix Combination Therapy for Uterine Fibroids
The NDA submission is supported by results from the phase 3 LIBERTY program.
Uterine Fibroids
Sustained Clinical Benefits Observed With Linzagolix in Uterine Fibroid Trials
Positive topline data were announced from two phase 3 studies evaluating the efficacy and safety of linzagolix (Yselty®; ObsEva) for the treatment of heavy menstrual bleeding due to uterine fibroids.
Oriahnn Approved for Heavy Menstrual Bleeding Due to Uterine Fibroids
The FDA has approved Oriahnn™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules; AbbVie) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Elagolix + Add-Back Tx Reduces Heavy Menstrual Bleeding in Phase 3 Extension Study
AbbVie plans to submit data from the phase 3 uterine fibroids program to the FDA sometime in 2019.
First-in-Class Oral Tx for Uterine Fibroids One Step Closer to Approval
Ulipristal acetate is a selective progesterone receptor modulator which acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland.
Fibroids Patient Information Fact Sheet
This patient information fact sheet provides information on the definition, causes, symptoms, diagnostic tests, treatments, and self-help measures for fibroids.
