The FDA delivered a blow to Spero's hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, which said another trial would be required to support approval.
Antimicrobial resistance has recently increased due to emerging carbapenem-resistant Klebsiella pneumoniae and extended-spectrum β-lactamase (ESBL)-producing strains of K. pneumoniae. Osaka ...
Carbapenem-resistant Enterobacterales (CRE), including carbapenem-resistant Klebsiella pneumoniae and carbapenem-resistant Escherichia coli, pose a major risk to patients and healthcare systems in ...