Elahere Granted Accelerated Approval for Platinum-Resistant Ovarian Cancer
The approval was based on data from the SORAYA trial.
Women’s Health
GSK: 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.
Liletta Approved for Pregnancy Prevention for Up to 8 Years
The approval was based on additional efficacy data from the ACCESS IUS trial.
Systemic Hormone Therapy During Menopause May Up Risk for Depression
Initiating systemic hormone therapy before age 50 years linked to increased risk for depression
NJ Supreme Court Reaffirms High Bar for Punitive Awards in Medical Malpractice Cases
This month’s case involves an FDA Safety Communication regarding a device which later caused injury that led to the death of a patient.
USPSTF Recommends Against Postmenopausal Hormone Tx to Prevent Chronic Conditions
The recommendations were give a “D” grade indicating that there is moderate or high certainty that the harms associated with hormone therapy use in these settings outweigh any potential benefits.
FDA Panel Recommends Makena Be Withdrawn From the Market
The product was granted approval through the accelerated approval pathway in 2011.
FDA Panel Meeting Scheduled to Discuss Rx-to-OTC Switch of Oral Contraceptive Opill
Opill contains 0.075mg of norgestrel, a single active steroid ingredient.
Fezolinetant NDA Accepted for Vasomotor Symptoms Associated With Menopause
Fezolinetant is an investigational, nonhormonal selective neurokinin-3 receptor antagonist.
FDA Approves Haloette Vaginal Hormonal Contraceptive Ring
Haloette is an estrogen/progestin combination hormonal contraceptive.
