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.
Obstetrics and Gynecology
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.
Mirena Approved for Pregnancy Prevention for Up to 7 Years
By the end of the 7th year, Mirena should be removed and replaced at the time of removal with a new system if continued use is desired.
Clindamycin Vaginal Gel Gets Priority Review for Bacterial Vaginosis
The product is designed as a one-time vaginally administered treatment.
Oteseconazole Gets Priority Review for Recurrent Vulvovaginal Candidiasis
The NDA submission is supported by data from three phase 3 trials, which included 2 global studies and one US-focused study.
Novel Oral Contraceptive Nextstellis Now Available
The approval was based on data from two phase 3 studies that evaluated the safety, acceptability, efficacy, and cycle control of Nextstellis in 3725 women aged 16 to 50.
FDA Cracks Down on Companies Selling Unproven Infertility Supplements
The claims made on these websites establish these products as drugs under the Federal Food, Drug, and Cosmetic Act; however, none were evaluated by the FDA.
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.
Novel Oral Therapy Fast Tracked for Reducing Postsurgical Abdominal Adhesions
LB1148 is an oral formulation of a broad spectrum serine protease inhibitor designed to neutralize the activity of digestive proteases released from the gut during surgery.
Vaginal pH Regulator Gets Fast Track Status for Gonorrhea Prevention
EVO100 is pH-modulating vaginal gel designed to reduce certain vaginal infections by balancing vaginal pH, thereby maintaining healthy vaginal flora.
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