FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

Jessica Zeller named director of the Office of Compliance and Enforcement, FDA Center for Tobacco Products

Jessica Zeller was named director of the Office of Compliance and Enforcement at the FDA Center for Tobacco Products.

October 23, 2026

FDA approves pembro or pembro + berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication

FDA has granted a traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high [≥13 mutations/megabase] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

October 23, 2026

Vol.52 No.39

Drugs & Targets

FDA approves bepirovirsen, first-of-its-kind chronic hepatitis B treatment

FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor therapy in adult patients without cirrhosis, receiving Nrtl therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid, and with hepatitis B virus surface antigen levels ≤3000 IU/ml, as determined by an FDA-authorized test.

October 23, 2026

Vol.52 No.39

Drugs & Targets

FDA clears TumorSight Risk, an AI-powered, MRI-derived breast cancer recurrence risk assessment

FDA has cleared TumorSight Risk, an AI-powered, MRI-derived prognostic tool for assessing breast cancer recurrence risk.

October 23, 2026

Vol.52 No.39

Drugs & Targets

FDA grants breakthrough device designation for Natera’s MCED assay

FDA has granted the Breakthrough Device designation to Natera Inc.’s multi-cancer early detection assay. The BDD is designed for novel technologies that could enable more effective diagnosis, treatment of life-threatening, or irreversibly debilitating diseases or conditions.

October 23, 2026

Vol.52 No.39

Cancer Policy

FDA launches Rare Disease Framework Initiative for drug development

FDA announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.

October 16, 2026

Vol.52 No.38

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee

Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

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Jessica Zeller named director of the Office of Compliance and Enforcement, FDA Center for Tobacco Products

FDA approves pembro or pembro + berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication

FDA approves bepirovirsen, first-of-its-kind chronic hepatitis B treatment

FDA clears TumorSight Risk, an AI-powered, MRI-derived breast cancer recurrence risk assessment

FDA grants breakthrough device designation for Natera’s MCED assay

FDA launches Rare Disease Framework Initiative for drug development

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