FDA Panel Votes on Rezafungin for Treatment of Candidemia, Invasive Candidiasis
Rezafungin is an investigational echinocandin antifungal that is administered once weekly.
Diagnosis & Disease Information
FDA Revises Evusheld EUA Halting Use of the COVID-19 Therapy for Now
Recent data show that the product is unlikely to be active against currently circulating SARS-CoV-2 variants.
NIH: Single Oral Dose of Azithromycin Cuts Risk of Postpartum Sepsis, Death
The study analyzed 29,278 women who were in labor at 28 weeks’ gestation or more and who were planning a vaginal delivery.
Fecal Microbiota Therapy Rebyota Now Available to Prevent CDI Recurrence
Rebyota is a fecal microbiota suspension for rectal administration.
Generic Version of Pylera an H. Pylori Treatment, Now Available
Each capsule contains 140mg of bismuth subcitrate potassium, 125mg of metronidazole, and 125mg of tetracycline hydrochloride.
Berdazimer Gel Under Review for Molluscum Contagiosum
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.
FDA Clears Single-Use PCR Test That Rapidly Detects STIs in Women
The test aids in the diagnosis of symptomatic or asymptomatic infections with C. trachomatis, N. gonorrhoeae, and T. vaginalis.
Bivalent RSV Maternal Vaccine Candidate Gets FDA’s Priority Review
The BLA is supported by data from a phase 3 trial which included approximately 7400 pregnant individuals.
Molnupiravir Misses Endpoint in COVID-19 Prevention Study
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.
FDA Adds OTC Eye Ointment to List of Possibly Contaminated Products
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.
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