EMBLAVEO (AZTREONAM+AVIBACTAM) Microbiology Testing for MDR Pathogens

The discussion emphasizes challenges in clinical antibiotic trials which failed to effectively target multi-drug resistant (MDR) pathogens. It advocates for using rapid PCR diagnostics to streamline trials, ensuring focus on pathogens of concern, and calls for regulatory adaptations to enhance study design and antibiotic testing efficacy. Continue reading EMBLAVEO (AZTREONAM+AVIBACTAM) Microbiology Testing for MDR Pathogens

An Intro to Emblaveo (aztreonam + avibactam)

The FDA web site usually provides label and review documents for approved drugs.[1]  Emblaveo, the combination of aztreonam and avibactam, was approved in February 2025, almost ½ year ago, but clinical review documents are still not posted at the site.[2]  Hence, we do not know how Regulators felt about the Continue reading An Intro to Emblaveo (aztreonam + avibactam)

The 10 x ’20 Goal – Are We On Track?

In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to oncology projects which had a much better ROI. The IDSA Continue reading The 10 x ’20 Goal – Are We On Track?