The FDA has reorganized and elevated its health IT, data management and cybersecurity efforts into a single, new office that will report directly to the commissioner. The move comes as part of the agency’s wider modernization strategy as it continues to face ever-increasing amounts of clinical data.

Mutations in tumor-suppressing genes are known to drive cancer, but how? Scientists long believed that the mutations prompted the cancerous cells to grow unchecked. But a new study out of Howard Hughes Medical Institute suggests the story is more complicated than that.

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing.

Protagonist Therapeutics’ treatment for a rare, slow-growing blood cancer is under an FDA clinical hold after the company reported safety concerns in a nonclinical mouse study.

Intellia has shown that gene editing works in the body, and now the biotech is going to try to prove the same outside of the body.

Aerie Pharmaceuticals earned the ire of Bio Twitter and investors Wednesday night after dropping a failed midstage study after-hours, then whitewashing the flop and insisting a phase 3 would go ahead anyway.