Bepirovirsen is the first therapy to offer people with chronic hepatitis B a shot at functional cure after a six-month course. It works in about one in five, and only in a narrow, already-treated population.
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Wound care is becoming one of big medtech's next frontiers, and Swedish wound-care leader Mölnlycke just announced a separation into an independent wound-care company. At the center of that landscape sits MediWound (NASDAQ: MDWD).
With only about 5% of rare conditions carrying an FDA-approved treatment, the agency is trying to turn case-by-case flexibility into written, predictable defaults. Whether that produces certainty or new rigidity is the open question.
AHEAD-MERIT missed its progression-free survival endpoint. In this disease, pembrolizumab itself never won PFS either. The trial now turns to overall survival, the endpoint where this cancer actually rewards immunotherapy.