FDA & Regulation, Drugs & Devices Vital Biomedical News Staff FDA & Regulation, Drugs & Devices Vital Biomedical News Staff

FDA Approves Hibsago, a First-of-Its-Kind Hepatitis B Drug That Lets Some Patients Stop Treatment

The FDA has approved Hibsago (bepirovirsen), GSK's injectable antisense drug for chronic hepatitis B. In two phase 3 trials, about 19% of patients achieved a functional cure and could stop all treatment. The drug carries a boxed warning for liver reactions and low platelets.

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FDA & Regulation, Drugs & Devices Katie Coffee FDA & Regulation, Drugs & Devices Katie Coffee

FDA Grants Accelerated Approval to Dostarlimab for dMMR Rectal Cancer, Opening a Path Around Surgery

The FDA has cleared GSK's immunotherapy Jemperli for a small, genetically defined group of patients with locally advanced rectal cancer. In trials, many avoided surgery, radiation and chemotherapy entirely, but the evidence comes from single-arm studies and longer follow-up is still required.

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FDA & Regulation Katie Coffee FDA & Regulation Katie Coffee

EU Regulators Back Daraxonrasib, the Pill That Nearly Doubled Survival in Advanced Pancreatic Cancer

Europe's medicines committee has recommended approval of daraxonrasib, an oral RAS-targeting drug for metastatic pancreatic cancer. In a 500-patient phase 3 trial, it extended median survival from 6.7 to 13.2 months compared with chemotherapy. Here is what the data show and what remains uncertain. On 26 August 2026, the FDA approved the oral drug daraxonrasib. Former US Senator Ben Sasse took it for stage 4 pancreatic cancer. It shrank his tumors and left him with a nasty bleeding skin rash.

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