The conversion to regular approval was based on data from an additional 141 patients with dMMR recurrent or advanced endometrial cancer who had progressed on or after a platinum-containing regimen.
The study analyzed 29,278 women who were in labor at 28 weeks’ gestation or more and who were planning a vaginal delivery.
The BLA is supported by data from a phase 3 trial which included approximately 7400 pregnant individuals.
Emzahh is an AB-rated generic equivalent of Ortho Micronor.
Experts discuss strategies to reduce the maternal mortality gap by implementing implicit bias training and reevaluating clinical guidelines and algorithms.
The approval was based on a re-analysis of data from on observational study of Tdap vaccine effectiveness in the US.
Mifepristone is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.
ACOG experts provide actionable steps to reduce the maternal mortality crisis in the US, particularly among minority populations.
Brexafemme is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids.
The decision to restrict the indication follows an FDA review of the double-blind, placebo-controlled phase 3 ENGOT-OV16/NOVA trial.
