Explore the latest findings from the KATHERINE, PATINA, and HER2CLIMB-05 trials, highlighting advancements and challenges in breast cancer treatment.

Written agreement from FDA for single-arm, open-label, baseline-controlled registrational trial evaluating composite primary endpoint of improvement in CGI-I and gain of developmental milestone/skill ...

A Swiss startup called Risklick has launched artificial intelligence software for clinical trials that the company claims can reduce development time and costs by as much as 35%, according to an April ...

Clinical software developer PhaseV is teaming up with another global CRO, unveiling a plan to infuse its trial design platform into Bioforum’s services. PhaseV’s Trial Optimizer uses machine learning ...

Breast cancer is the second leading cause of cancer deaths in the U.S. and worldwide, pointing to the continuing need to improve treatment strategies and therapies that better patient survival and ...

Positive End of Phase 2 discussion with FDA, including alignment on Phase 3 design Bayley-4 expressive communication selected as Phase 3 study primary endpoint Initiation of ION582 Phase 3 study ...

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics ...

Design Therapeutics, Inc. announced the initiation of a Phase 1 clinical trial for its gene-targeted treatment DT-216P2 in healthy volunteers, with patient dosing for Friedreich Ataxia (FA) set to ...

Head and neck cancer trials are frequently derailed before they can deliver answers. A new analysis suggests that the most ...

What Happened: The New York-based clinical-stage biopharmaceutical company received final meeting minutes from the U.S. Food and Drug Administration confirming alignment on a registrational path for ...