FDA accepts Venatorx’s NDA for cefepime-taniborbactam antibiotic
The regulatory agency has granted priority review for this NDA with Prescription Drug User Fee Act (PDUFA) target action date of 22 February next year. It earlier granted
The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).