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Live News REGULATION ARTICLE M impact

GSK Wins US Approval for Hepatitis B Drug Hibsago

GSK said Hibsago was cleared under priority review and breakthrough therapy designation. Phase III B—Well data supported the decision, according to the company.

GSK

GSK said the drug was cleared under priority review and breakthrough therapy designation, with the regulator recognising its ability to deliver functional cure rates far above the current standard of care.The FTSE 100-listed firm stated the decision was underpinned by phase III B—Well data showing…