FDA Approves Brexafemme for Recurrent Vulvovaginal Candidiasis
Brexafemme is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids.
Brexafemme is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids.
The product is administered rectally 24 to 72 hours after the last dose of antibiotics for CDI.
The recalled product was distributed between October 26, 2021 and August 10, 2022.
The guidance provides steps to address the potential for cross-contamination.
Immune responses after Priorix administration were noninferior to those observed with M-M-R II.
The approval was based on data from the open-label phase 3 AHOD1331 trial.
A significant percentage of affected patients were observed to have dilated atria and left ventricular hypertrophy.
The vote was mixed when the data was reviewed for younger patients.
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
The product was granted approval through the accelerated approval pathway in 2011.