Ahead of an Antimicrobial Drugs Advisory Committee meeting on Monday, FDA reviewers voiced ongoing concerns about the benefits versus risks of a novel oral antibiotic for the treatment of ...
(RTTNews) - Iterum Therapeutics plc (ITRM) has been notified by the FDA that an Advisory Committee meeting to review the company's new drug application for Sulopenem etzadroxil/probenecid is no longer ...
The FDA approved oral sulopenem etzadroxil and probenecid (Orlynvah) to treat uncomplicated urinary tract infections (uUTIs) caused by certain bacteria in women with limited or no alternative oral ...
The treatment has been shown to be active against third generation cephalosporin-resistant Enterobacterales species. Orlynvah combines sulopenem etzadroxil, a penem antibacterial drug, and probenecid, ...
DUBLIN and CHICAGO, May 31, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV ...
Panelists discuss how sulopenem etzadroxil/probenecid, approved in October 2024, functions as an oral β-lactam/β-lactamase inhibitor effective against extended-spectrum β-lactamase producers per SURE ...
The REASSURE trial was conducted to support the approval of the product following a letter from the FDA requesting additional study data. Sulopenem etzadroxil ...
Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an ...
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