ArriVent's firmonertinib beat chemotherapy on investigator reads in a 398-patient Phase 3, but the blinded central review it chose returned p=0.0654, and first-line EGFR exon 20 lung cancer now belongs to combinations that keep chemotherapy in the regimen.
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KRAS sat on the undruggable list for decades. Silexion's SIL204 is built to silence the mutation earlier in the cell, and the Phase 2/3 program is now moving into patients.
Lilly's once-weekly insulin Onswik is the second FDA approval in a six-month window, after Novo's Awiqli. Both won on non-inferiority data, leaving the real question open: whether weekly dosing actually improves insulin initiation and adherence.
The FDA approved Atebrioz for FOP on a change in new bone volume, a measure the trial registry listed as secondary, after the lesion-count primary missed statistical significance at week 24.