Originally slated to be released this summer, the guidance will detail the formal steps involved in qualifying biomarkers for FDA approval.
An FDA official said that the agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.
The US Food and Drug Administration has approved Kite Pharmaceuticals' CAR T-cell therapy for large B-cell lymphomas, the New York Times reports.
Kaiser Health News reports that gene therapies could cost more than a million dollars.
Worcester Polytechnic Institute researchers have received a grant to combine biology and computer science for high school students.
In Nature this week: variants associated with obsessive-compulsive disorder, review of key CRISPR enzymes, and more.