All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.
The FDA has accepted Eyenovia Inc.’s new drug application (NDA) for Mydcombi, a fixed combination pupil dilation agent, with a PDUFA date of Oct. 28, 2021.
Mycovia Pharmaceuticals Inc. said new phase III data on its oral antifungal, oteseconazole, showed that 37 weeks after women with a history of recurrent vulvovaginal candidiasis received a dose of the medicine for an episode of acute yeast infection, just 5.1% saw a recurrence of infection vs. 42.2% of those treated with fluconazole. Furthermore, oteseconazole proved noninferior to fluconazole in the resolution of symptoms at day 14 of the study.
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).
