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Biocryst Announces FDA Acceptance Of NDA For Orladeyo (Berotralstat) Oral Granules In Patients With Hereditary Angioedema Aged 2 To 11 Years

ReutersMay 14, 2025 11:55 AM

- BioCryst Pharmaceuticals Inc BCRX.O:

  • BIOCRYST ANNOUNCES FDA ACCEPTANCE OF NDA FOR ORLADEYO® (BEROTRALSTAT) ORAL GRANULES IN PATIENTS WITH HEREDITARY ANGIOEDEMA AGED 2 TO 11 YEARS

  • BIOCRYST PHARMACEUTICALS INC: FDA GRANTS PRIORITY REVIEW OF APPLICATION, WITH PDUFA TARGET ACTION DATE OF SEPTEMBER 12, 2025

  • BIOCRYST PHARMACEUTICALS: FILED LINE EXTENSION APPLICATION FOR USE OF ORLADEYO ORAL GRANULES IN PATIENTS WITH HAE AGED 2-11 YEARS WITH EMA

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