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The FDA clears the first-ever newborn test to detect Severe Combined Immunodeficiency.

The U.S. Food and Drug Administration (FDA) has cleared the EnLite Neonatal TREC Kit for the company PerkinElmer, the first screening test permitted to be marketed by FDA for Severe … Continue Reading The FDA clears the first-ever newborn test to detect Severe Combined Immunodeficiency.

Dosage determined in landmark human study of stem cell therapy for heart attack.

Patients who receive more cells get significant benefits. That’s a key lesson emerging from a clinical trial that was reported at the American Heart Association meeting in Chicago. In this … Continue Reading Dosage determined in landmark human study of stem cell therapy for heart attack.

FDA approves world’s first non-invasive DNA screening test for colorectal cancer.

The U.S. Food and Drug Administration has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the … Continue Reading FDA approves world’s first non-invasive DNA screening test for colorectal cancer.

Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment.

Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment. Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events. The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process.

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