FDA Panel Votes on Rezafungin for Treatment of Candidemia, Invasive Candidiasis
Rezafungin is an investigational echinocandin antifungal that is administered once weekly.
Rezafungin is an investigational echinocandin antifungal that is administered once weekly.
Recent data show that the product is unlikely to be active against currently circulating SARS-CoV-2 variants.
The study analyzed 29,278 women who were in labor at 28 weeks’ gestation or more and who were planning a vaginal delivery.
Rebyota is a fecal microbiota suspension for rectal administration.
Each capsule contains 140mg of bismuth subcitrate potassium, 125mg of metronidazole, and 125mg of tetracycline hydrochloride.
The application is supported by data from the pivotal phase 3 B-SIMPLE4 study which included 891 patients 6 months of age and older with molluscum contagiosum.
The test aids in the diagnosis of symptomatic or asymptomatic infections with C. trachomatis, N. gonorrhoeae, and T. vaginalis.
The BLA is supported by data from a phase 3 trial which included approximately 7400 pregnant individuals.
The MOVe-AHEAD study enrolled over 1500 participants 18 years of age and older who resided in the same household with someone who tested positive for SARS-CoV-2.
Earlier this month, Global Pharma Healthcare had announced a nationwide recall of its artificial tear lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma.