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The NDA for the gonorrhea indication is supported by data from the EAGLE-1 study, which compared the safety and efficacy of oral gepotidacin to a standard of care combination.
Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million ...
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Stockhead on MSNFDA Waiting Room: For Aussie applicants, it’s (mainly) business as usualDespite its well-publicised problems, the US FDA is a happy place for ASX biotechs seeking drug or device approvals. ... Read ...
Jon Walsh, founder, chief scientific officer, Unlearn, explains how regulators are clarifying best practices for integrating AI and digital twins into clinical research.
Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launchDNL126 accelerated approval path ...
Arcascope — a circadian health company — is leveraging its combination of AI, mathematical models and wearable devices to ...
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