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- Geron halts phase 3 Rytelo trial after data monitoring panel deems unlikely to improve survival in JAK-inhibitor-pretreated myelofibrosisGeron announced the discontinuation of its phase 3 IMpactMF trial of Rytelo (imetelstat) in patients with myelofibrosis who had previously failed JAK inhibitor therapy. The decision followed an in…
- FDA drafts guidance to speed approvals of individualized gene therapies, hailed as win for rare disease patientsThe U.S. Food and Drug Administration released draft guidance aimed at streamlining the approval process for certain individualized gene therapies. The proposal would allow sponsors to avoid filing…STAT · 13d agoRegulatoryNeutral