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.
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.
The US FDA has cleared the first ever direct blood test for detection of five yeast pathogens that cause bloodstream infections; Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata … Continue Reading FDA clears the world’s first test to identify five yeast pathogens directly from blood.
A simple point-of-care testing device for anemia could provide more rapid diagnosis of the common blood disorder and allow inexpensive at-home self-monitoring of persons with chronic forms of the disease. … Continue Reading FDA-funded study for one-minute point-of-care anemia test shows promise.
The US FDA has cleared the NephroCheck test, a first-of-a-kind laboratory test to help determine if critically ill hospitalized patients are at risk of developing moderate to severe acute kidney … Continue Reading The FDA clears first-ever test to assess risk of developing acute kidney injury.
The FDA has approved the world’s first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. … Continue Reading FDA approves world’s first ZnT8Ab autoantibody test to diagnose type 1 diabetes.
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.
Thoughts health innovators?
To begin a QR code or Quick Response code is a 2-dimensional barcode which can be linked to a website or contain extra documentation, there’s one over there to the … Continue Reading Healthinnovations on QR codes in pharma & healthcare marketing.
Following trends in my sector always enables me to smell a new wave movement the size of a Tsunami coming. The first inkling I got were the release of statistics … Continue Reading Will Obesity Become The New Cancer