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.

Shares of Tiziana Life Sciences gained after the biotechnology company said the Food & Drug Administration approved the investigational new drug application for a trial of its treatment for multiple ...

Patients on a combination of toripalimab and RemeGen's anti-HER2 antibody disitamab vedotin fared better than those on a chemotherapy regimen.

The FDA accepts a new drug application for vepdegestrant, a promising oral PROTAC developed by Arvinas and Pfizer, signaling ...

British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority ...

A new two-phase initiative aims to streamline facility approvals, reduce reliance on foreign pharmaceutical production, and ...

Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or ...

Eli Lilly’s orforglipron cut body weight to a lesser extent than rival Novo Nordisk’s semaglutide, falling into analysts’ ...

“All we can do now is give them trazodone two hours before a storm and try to comfort them,” Cantwell said. Anti-anxiety ...

R&D expense was $11.7 million for the three months ended June 30, 2025, compared to $7.6 million for the same period in 2024. The increase was primarily driven by higher research, development, ...

Pipeline Regulatory Progress -- Two risk-adjusted product launches (AMP-002 and AMP-015) are included in the flat full-year ...

Newly developed DNA nanostructures can form flexible, fluid, and stimuli-responsive condensates without relying on chemical ...