GlaxoSmithKline plc (GSK) says the US Food and Drug Administration (FDA) has approved its anti-IL-5 biologic Nucala (mepolizumab) in a 40 mg pre-filled syringe for children aged 6 to 11 years old with severe eosinophilic asthma (SEA).
Biopharmaceutical company ImmixBio has been granted Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for IMX-110 for the treatment of a life-threatening form of pediatric cancer in children, rhabdomyosarcoma.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.