The NDA included data from two Phase 3 clinical trials (VENUS I and VENUS II), all four Phase 3 European Union registration studies, and real-world data of >700,000 women with uterine fibroids across 80 countries.
Hydroxyprogesterone Caproate is used to lower the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Healthcare professionals and patients should check Gonal-f products for possible tampering before use; purchases should only be made through licensed wholesale distributors and pharmacies.
The FDA approval was supported by findings from a Phase 3, randomized, double-blind, placebo-controlled study that evaluated Imvexxy (4mcg and 10mcg) vs placebo from baseline to week 12.
In both pivotal trials, a statistically significant greater percentage of treatment patients experienced clinical response vs those treated with placebo at 21 to 30 days following a single dose.
The authors concluded, "There is high-certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and young women aged 15 to 26," while also indicated that future studies should have long-term follow-up.
Study quality was graded according to the United States Preventive Services Task Force and the Cochrane Risk of Bias Tools.
The approval of Verzenio as initial therapy in combination with an aromatase inhibitor is based on the efficacy and safety demonstrated in the pivotal MONARCH 3 clinical trial.
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.
The FDA's approval of the supplemental New Drug Application (sNDA) was based on efficacy and safety data from the ongoing Phase 3 ACCESS IUS trial.
The safety and efficacy of topical minoxidil for the treatment of female pattern hair loss was supported by moderate to low quality evidence in a recent Cochrane systematic review.