Science
FDA Probes Tumour Risk Linked to Novartis Gene Therapy Zolgensma
The FDA is investigating a serious tumour risk linked to Novartis gene therapy Zolgensma after two children's tumours showed evidence…
FDA
Science
FDA Grants Orphan Status to Drug for Newborn Brain Injury
The FDA has granted orphan drug designation to Neuren Pharmaceuticals' NNZ-2591 for neonatal hypoxic-ischemic encephalopathy, a brain injury caused by…
Science
FDA Fast-Tracks Sleep Drug for Children With Insomnia
The FDA has granted breakthrough status to daridorexant for insomnia in children aged 10 to under 18. The designation could…