CHMP recommends Fetcroja, intended for the treatment of infections due to aerobic Gram-negative organisms .- Shionogi
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Iterum Therapeutics plc , a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings,announced that, based on discussions at a pre-NDA meeting with the FDA, it plans to proceed with an NDA submission for sulopenem etzadroxil/probenecid, a bilayer tablet, for the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone-resistant pathogen.
Spero Therapeutics announced positive topline results from ADAPT-PO, the pivotal Phase III clinical trial evaluating Spero’s oral antibiotic candidate, SPR 994 (tebipenem HBr), for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
Iterum Therapeutics announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 phase III clinical trial in complicated urinary tract infection (cUTI).