Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult Women
Iterum Therapeutics plc - Ordinary Share (ITRM)
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm
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Source: GlobeNewswire
FDA Decision Expected by PDUFA Goal Date of October 25, 2024 Potential to be First Oral Penem Approved in the U.S. DUBLIN and CHICAGO, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced that a meeting of the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) took place on September 9, 2024 at which Iterum’s new drug application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTI) in adult women was discussed. Specifically, the FDA convened the AMDAC meeting to discuss a) the overall benefits and risks for the use of sulopenem etzadroxil/probenecid for the treatment of uUTI caused by designated susceptible microorganisms in adult women 18 years of
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- Iterum Therapeutics Regains Full Nasdaq Compliance [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics Regains Full Nasdaq ComplianceGlobeNewswire
- Iterum Therapeutics Reports Third Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics Reports Third Quarter 2024 Financial ResultsGlobeNewswire
- Iterum Therapeutics to Report Third Quarter 2024 Financial Results on November 14, 2024GlobeNewswire
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