ITRM ITERUM THERAPEUTICS PLC Product Launches 8-K Filing 2024 - FDA Approval Iterum Therapeutics announced FDA approval for ORLYNVAH, its first product, to treat uncomplicated urinary tract infections in women with limited treatment options, based on successful Phase 3 trials. The company plans to explore strategic transactions to maximize value from ORLYNVAH, which addresses a significant market need with approximately 40 million uUTI prescriptions annually in the U.S.Get access to all SEC 8-K filings of the ITERUM THERAPEUTICS PLC