Launches·October 21, 2026 at 6:12 AM EDT·3 sources
GSK gets FDA approval for hepatitis B drug that offers functional cure
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News
What happened
- The FDA approved GSK and Ionis’ chronic hepatitis B drug bepirovirsen, branded Hibsago.
- The approval came earlier than expected and could position Hibsago for eventual blockbuster status.
Why it matters
The approval gives GSK and Ionis a new commercial opportunity in chronic hepatitis B and introduces a treatment described as offering a functional cure.
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Timeline
- EarlierOct 12GSK to invest $800M for new R&D, manufacturing hub in Pennsylvania
- EarlierOct 14GSK could cut more than 1,200 jobs in Belgium
- EarlierOct 19#ESMO26 regular abstracts featuring Zai Lab, GSK, Merck and more
- First reported by Endpoints NewsOct 21GSK gets FDA approval for hepatitis B drug that offers functional cure
- STAT reportsOct 21STAT+: GSK picks up hep B drug approval
- BioPharma Dive reportsOct 21GSK, Ionis win US approval for first-of-its-kind hepatitis B drug
Who is involved
GSK gets FDA approval for hepatitis B drug that offers functi…GSKGSKIonisHibsagoU.S. Food and Drug Administration
CompanyAgency
Sources (3)
- Endpoints NewsOct 21GSK gets FDA approval for hepatitis B drug that offers functional cure
- STATOct 21STAT+: GSK picks up hep B drug approval
- BioPharma DiveOct 21GSK, Ionis win US approval for first-of-its-kind hepatitis B drug
Related
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