The US Food and Drug Administration (FDA) is proposing a new “plausible mechanism” pathway that will enable the limited approval of bespoke therapies when randomized trials are impractical. FDA will ...
Avutometinib plus defactinib granted priority review by FDA, under the accelerated approval pathway, for recurrent KRAS mutant LGSOC; PDUFA action date set for June 30, 2025 Potential U.S. commercial ...
CKD and VHD share metabolic, inflammatory, and fibrotic pathways, worsening each other's progression and complicating management. An integrated care model involving nephrologists, cardiologists, and ...
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