Posted by Michael Wonder on 15 May 2025
BioCryst announces FDA acceptance of NDA for Orladeyo (berotralstat) oral granules in patients with hereditary angioedema aged 2 to 11 years
14 May 2025 - FDA grants priority review of application, with PDUFA target action date of 12 September 2025.
BioCryst Pharmaceuticals today announced that the US FDA has accepted its new drug application for the use of oral, once-daily Orladeyo (berotralstat) in paediatric patients with hereditary angioedema aged 2 to 11 years.
