Regulatory Requirements

board meeting
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
Redbrick building with Sarepta name and logo

Sarepta cites 'overburdened' FDA as factor in gene therapy delay

Sep 11, 2020 6:40am
Robert Califf

FDA under fire over accelerated approval data demands

Aug 16, 2017 8:45am
Emily OReilly

EU watchdog asks if drugmakers influence EMA decisions

Jul 19, 2017 9:11am
The Palace of Westminster

U.K. politicians push for cooperation with EMA post-Brexit

Jul 5, 2017 4:17am
Scott Gottlieb

Gottlieb ends FDA hiring freeze, lays out R&D priorities

May 26, 2017 5:33am