The FDA has issued a draft guidance to simplify the procedure of developing drugs for rare pediatric disorders.
The US Food and Drug Administration has approved the supplemental Biologics License Application for blinatumomab (BLINCYTO®) to include new findings supporting the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
According to a comprehensive analysis in JAMA Pediatrics, screening newborns for congenital cytomegalovirus infection, whether universal or targeted, is a cost-effective practice.
Men exposed to dioxin, a chemical once common in herbicides, may be less likely to father boys than peers who didn't come in contact with this toxin, a recent study suggests.
The FDA announced the recall of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate tablets (mixed salts of a single entity amphetamine product).