Brief: Biocryst Announces FDA Acceptance Of NDA For Orladeyo (Berotralstat) Oral Granules In Patients With Hereditary Angioedema Aged 2 To 11 Years
14/05/2025 12:55
May 14 (Reuters) - 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 Source text: ID:nGNXb5BYG9 Further company coverage: BCRX.O ((Reuters.Briefs@thomsonreuters.com;))
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