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.
Dysmenorrhea
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.
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.
Clinically Meaningful Pain Reduction Observed With Relugolix in Endometriosis Trial
Positive topline results were announced from the phase 3 SPIRIT 1 study investigating relugolix (Myovant Sciences), in combination with estradiol and norethindrone acetate, in women with pain associated with endometriosis.
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.
FDA Approves OTC Combination of Ibuprofen and Acetaminophen
The FDA has approved Advil Dual Action with Acetaminophen (GlaxoSmithKline), the first over-the-counter (OTC) fixed-dose combination therapy containing ibuprofen and acetaminophen for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis. Each caplet contains 125mg of Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID)…
