esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study
AI Summary: The FDA has granted full approval for ziftomenib—a novel agent aimed at treating relapsed or refractory acute myeloid leukemia, especially in patients with NPM1 mutations. Backed by the KO‐MEN‐001 trial data, this decision marks a significant step forward for a patient group in dire need of new therapeutic options.
FDA Lifts Hold on Intellia’s Phase 3 Gene Editing Trial / 4 months
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FDA updates Sarepta gene therapy label with severe warnings / 6 months
FDA clears AstraZeneca’s new blood-pressure drug baxdrostat / 13 days
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