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Regulatory Requirements
Biotech
FDA said no in July, so Iterum will test UTI antibiotic again
Iterum Therapeutics will give its uncomplicated UTI antibiotic a second shot at FDA approval by conducting another phase 3 trial.
Kyle LaHucik
Sep 29, 2021 10:05am
Sarepta cites 'overburdened' FDA as factor in gene therapy delay
Sep 11, 2020 6:40am
FDA under fire over accelerated approval data demands
Aug 16, 2017 8:45am
EU watchdog asks if drugmakers influence EMA decisions
Jul 19, 2017 9:11am
U.K. politicians push for cooperation with EMA post-Brexit
Jul 5, 2017 4:17am
Gottlieb ends FDA hiring freeze, lays out R&D priorities
May 26, 2017 5:33am