The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 31 new products so far in 2019. In 2018 FDA […]readmore
Tags : Nabriva
OxThera’s Oxabact Receives EMA’s Positive Decision on Pediatric Investigational Plan to Treat Primary Hyperoxaluria Published: Aug 23, 2019 | Tags: OxThera, Oxabact, Receives, EMA, Positive Decision, Pediatric Investigational Plan, Treat, Primary […]readmore
Shots: The US FDA’s approval is based on two P-III studies, LEAP 1 & LEAP 2. LEAP 1 involves assessing of Xenleta (150mg IV/600mg oral for 5-7days) vs moxifloxacin (IV/oral […]readmore