Since 2012, the FDA can designate a drug as a "breakthrough therapy" if preliminary clinical evidence - such as an improvement in a pharmacodynamic biomarker - suggests an advantage over existing options. The term is routinely used in press releases and prescribing resources. Although the term breakthrough leads consumers to overly optimistic beliefs about drug effectiveness, it is not known how physicians understand this term, or more generally, what FDA approval means.

Enrollment has begun in the first of two multinational clinical trials of an intravenously delivered investigational antibody for preventing HIV infection. Known as the AMP Studies, for antibody-mediated prevention, the trials will test whether giving people an investigational anti-HIV antibody called VRC01 as an intravenous infusion every 8 weeks is safe, tolerable and effective at preventing HIV infection.

Researchers at Massachusetts General Hospital (MGH) have identified a type of immune cell that appears to block the progress of melanoma and other cancers in animal models. These subcapsular sinus (SCS) macrophages form a protective coating around lymph nodes, preventing the entry of tiny structures that transport bits of tumor tissue and help the cancer to grow and spread.

Nanoparticles designed to block a cell-surface molecule that plays a key role in inflammation could be a safe treatment for inflammatory bowel disease (IBD), according to researchers in the Institute for Biomedical Sciences at Georgia State University and Southwest University in China.

The results of the ground-breaking SALOME research, published in the Journal of the American Medical Association (JAMA) Psychiatry, show chronic heroin addiction now has another effective treatment tool - hyrdomorphone, a licensed pain medication. SALOME, which stands for the Study to Assess Longer-term Opioid Medication Effectiveness, found hydromorphone (HDM) to be as effective as diacetylmorphine

A daily dose of vitamin D3 improves heart function in people with chronic heart failure, a five-year University of Leeds research project has found. Dr Klaus Witte, from the School of Medicine and Consultant Cardiologist at Leeds Teaching Hospitals NHS Trust, led the study, known as VINDICATE.

How vascular tubes build, maintain and adapt continuously perfused lumens to meet local metabolic needs remains poorly understood. Recent studies showed that blood flow itself plays a critical role in the remodelling of vascular networks and suggested it is also required for the lumenization of new vascular connections.