Kumquat, based in San Diego, received US Food and Drug Administration clearance of its investigational new drug application for the KRAS G12D inhibitor in July. The firm will be responsible for ...

Travere Therapeutics has successfully executed a significant restructuring to recover from previous setbacks and improve its ...

The FDA accepted vepdegestrant’s new drug application for ER+/HER2–, ESR1-mutated advanced breast cancer with a June 5, 2026, ...

The U.S. Food and Drug Administration has approved Insmed's oral drug for a type of lung disease, the company said on Tuesday ...

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

Phase 1b/2a immune thrombocytopenia (ITP) trial FPI achieved, enrollment ongoing. Climb Bio is enrolling an open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in patients with ITP to ...

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.

Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate ...

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

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 ...

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