BioCryst announces acceptance of regulatory applications for Orladeyo (berotralstat) by Health Canada and Swissmedic

BioCryst Pharmaceuticals

25 August 2021 - BioCryst Pharmaceuticals today announced that the new drug submission for Orladeyo (berotralstat) has been accepted for review by Health Canada for the prevention of recurrent attacks in patients with hereditary angioedema 12 years and older. 

The company also announced that Swissmedic has accepted BioCryst’s marketing authorization application for Orladeyo for review.

Read BioCryst Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , Canada , Dossier , Switzerland