News|Articles|September 30, 2026

Q4 2026 Preview: 7 FDA Decisions to Watch

Fact checked by: Victoria Johnson

Preview the biggest anticipated FDA decisions of Q4 2026, including bepirovirsen for CHB, obinutuzumab for pMN, bezuclastinib for systemic mastocytosis, and more.

Q4 opens with a concentrated slate of regulatory decisions spanning hepatology, nephrology, cardiovascular disease, endocrinology, and dermatology. October begins with what could be a first-in-class hepatology approval as the US Food and Drug Administration (FDA) weighs bepirovirsen for chronic hepatitis B (CHB). The antisense oligonucleotide (ASO) is positioned as the first therapy to deliver clinically meaningful functional cure rates.

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