AstraZeneca's fifth Ultomiris indication arrives on a proteinuria surrogate, while the week-106 eGFR readout still decides whether the drug actually saves kidneys.
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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).
Verastem's 900 mg KRAS G12D dose posted a 50% confirmed response rate in second-line pancreatic cancer, and the company will take a chemotherapy-free regimen into a first-line Phase 3. The rival comparison is overall survival.
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.