FDA expanded Anktiva's use to BCG-unresponsive, high-grade papillary-only bladder cancer without a dedicated trial, leaning on earlier carcinoma in situ data and scientific similarities. The move sets a precedent developers of rare indications will study closely.
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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).
The FDA's 321-page review of Rasonque documents the survival win that earned a broad pancreatic cancer label, and the mutation subgroups whose response data ran against the drug.
A Nature paper finds that one arginine transfer RNA, tRNA1 Arg(UCU), keeps prostate tumors on androgen receptor signaling. When it falls, cells slip into a lineage-plastic, AR-inhibitor-resistant state.