FDA Accepts BioCryst’s NDA for Berotralstat Oral Granules in Children With HAE

FDA awards BioCryst's Orladeyo NDA for paediatric HAE

The US Food and Drug Administration (FDA) has accepted BioCryst Pharmaceuticals’ new drug application (NDA) for Orladeyo.

FDA Accepts BioCryst’s NDA for Berotralstat Oral Granules in Children With HAE

FDA accepts BioCryst’s NDA for berotralstat oral granules in kids with HAE; priority review granted. Approval could bring first oral prophylactic for kids aged

FDA accepts NDA for berotralstat in HAE patients aged 2 to 11 years

The federal agency provided BioCryst Pharmaceuticals a target action date of September 12, 2025 for potential approval of berotralstat (ORLADEYO).