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.

Despite its well-publicised problems, the US FDA is a happy place for ASX biotechs seeking drug or device approvals. ... Read ...

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 ...

A new pill that combats antibiotic-resistant strains of gonorrhoea has inched closer to approval in the US, after the US Food and Drug Administration (FDA) accepted GSK’s gepotidacin for priority ...

First Patient Dosing Expected in Q1 2026 • Clinical Trial to Prioritize Biomarker-Selected RBM39-Dependent Cancers KING OF ...

Alzinova AB (publ) (Nasdaq First North: ALZ) today announced that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the planned P ...

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