Trending News Today: FDA Accepts NDA for Topical Rosacea Treatment

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Officials with the FDA have accepted the New Drug Application for FMX103 (minocycline topical foam 1.5%, Foamix Pharmaceuticals), a topical foam for the treatment of moderate-to-severe papulopustular rosacea in adults, MD Magazine reported. According to the article, the new application follows a pair of 12-week phase 3 efficacy and safety trials, as well as a 40-week open-label safety extension trial, which all met both co-primary endpoints of statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success. The FDA has set June 2, 2020, as the Prescription Drug User Fee Act action date, the article reported.

A new study found that the risk of serious infection for patients with multiple sclerosis (MS) varies depending on their treatment, The American Journal of Managed Care reported. According to the article, the study researchers analyzed data from a total of 6421 patients with MS, with a comparator cohort of 42,645 individuals. Overall, patients with MS on rituximab had the highest rate of antibiotic use, followed by natalizumab and fingolimod, and interferon β and glatiramer acetate, the article reported.

Researchers from NYU School of Medicine and the NYU Center for Data Science found that an artificial intelligence (AI) tool identified breast cancer with approximately 80% accuracy when combined with analysis by radiologists, NYU Langone reported. According to the press release, the study examined the ability of a machine learning computer program to add value to diagnoses reached by a group of 14 radiologists as they reviewed 720 mammogram images. Moving forward, the team plans to further increase this accuracy by training the AI program on more data, such as identifying changes in breast tissue that are not yet cancerous but have the potential to be, the article reported.