Zejula Use for Second-Line Maintenance Treatment Restricted
The decision to restrict the indication follows an FDA review of the double-blind, placebo-controlled phase 3 ENGOT-OV16/NOVA trial.
Obstetrics and Gynecology
Elahere Granted Accelerated Approval for Platinum-Resistant Ovarian Cancer
The approval was based on data from the SORAYA trial.
Liletta Approved for Pregnancy Prevention for Up to 8 Years
The approval was based on additional efficacy data from the ACCESS IUS trial.
Case Study: 2-Rod Subdermal Contraceptive Implant in a Recent Immigrant
Case involving a 2-rod subdermal contraceptive implant mistaken for a 1-rod device demonstrates the importance of delivering culturally competent care.
Maternal RSV Vaccine Candidate Provides Protection for Infants in Phase 3 Trial
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
Antidepressant Use in Pregnancy Underused: Provider and Patient Perspectives
Authors describe the perspectives of patients and prescribing clinicians regarding the use of antidepressants during pregnancy.
FDA Panel Recommends Makena Be Withdrawn From the Market
The product was granted approval through the accelerated approval pathway in 2011.
HDL Is Not Always Good Cholesterol During Menopause Transition
Data from the large-scale SWAN study suggest a rethinking of HDL as beneficial for women in late perimenopause and postmenopause.
Diet Contributes to Menstrual Pain in Teens
Researcher identifies inflammatory foods linked to menstrual pain in teenagers.
Vaginal pH Modulator Misses Primary Endpoint in STI Clinical Trial
Topline results were announced from a phase 3 trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women.
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