The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...

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.

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the ...

US FDA accepts for priority review GSK’s sNDA for gepotidacin for oral treatment of uncomplicated urogenital gonorrhoea: London, UK Tuesday, August 12, 2025, 10:00 Hrs [IST] GSK ...

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 ...

This week, students up and down the country will find out their A-level results so we’ve produced the following guide to help ...

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 ...

Wilmington, Delaware Tuesday, August 12, 2025, 16:00 Hrs [IST] ...

Officials are exploring buffer zones where amplified sound would be prohibited after complaints from residents about ...

Going out to eat? See which Marion County restaurants were rated best by inspectors, and which failed the test.

For full restaurant inspection details, visit our Lake County restaurant inspection site. These restaurants met all standards during their Aug. 4-10 inspections and no violations were found. ** ...

With food policy remaining a top priority for the Trump Administration, the U.S. Food and Drug Administration (FDA), acting under Health and ...