Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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)
Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP. Ten years later and after an FDA rejection CRL in 2021, Continue reading Sulopenem uUTI – Does It Suffice?
GSK’s pipeline in anti-infectives is impressive. It comprises drugs for bacterial, mycobacterial, fungal, viral infections, and for malaria; in addition, they have a number of vaccines in development. Several antibiotics are listed on their website targeting UTI pathogens, and one of them was just approved, namely gepotidacin / Blujepa, a Continue reading BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1