FDA Alerts
First Flu Vaccine with Adjuvant Approved
The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant.
Anthrax Vaccine Gets FDA Nod
The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.
Rare Blood Disorder Rx Approved for Kids
The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP).
Rx for Rare Metabolic Conditions Approved
Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).
First Screening Test for Group of Newborn Genetic Disorders Gets FDA Thumbs Up
The U.S. Food and Drug Administration today allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.
FDA Warns of Risk in Children's Use of Dietary Supplement
FDA is warning health professionals of the risks associated with the regarding use of dietary supplements containing live bacteria or yeast in immunocompromised persons.
Parents Warned to Not Use Product Due to Potential Lead Poisoning Risk
FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd. due to the potential lead poisoning risk associated with the product.
FDA Issues Advice on Eating Fish
The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency today issued draft updated advice on fish consumption.
FDA Okays Tool to Spot Developmental Delay
Today the U.S. Food and Drug Administration authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability.
FDA Permits Marketing Test to Help Assess Children and Teens for ADHD
The US Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old.