Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-12-23

FDA Approved: ORLADEYO — Supplemental Application (BioCryst Pharmaceuticals, Inc.)

View source ↗

Summary

FDA approval of a supplemental application for ORLADEYO (berotralstat hydrochloride) submitted by BioCryst Pharmaceuticals, Inc.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • ORLADEYO (berotralstat hydrochloride)

Snippet

SUPPL AP for ORLADEYO (BEROTRALSTAT HYDROCHLORIDE)