Tags : Fetroja

Insights+: The US FDA New Drug Approvals in November 2019

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year’s record of approvals. However, there is a significant […]Read More

Shionogi’s Fetroja (cefiderocol) Receives the US FDA’s Approval for the

Shots: The US FDA approval is based on APEKS-cUTI study assessing Fetroja vs imipenem/cilastatin (IPM/CS) in patients aged ≥18yrs. with cUTI who have limited or no alternative treatment options The pivotal APEKS-cUTI study resulted in higher response rate in microbiological eradication and clinical response at the test of cure (TOC), met its 1EPs (72.6% vs […]Read More