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European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process

Revolution Medicines (RVMD)Revolution MedicinesFDA / regulatory

Phased review by EMA aims to accelerate assessment of company's investigational drug daraxonrasib in pancreatic cancer based on unprecedented clinical results from pivotal Phase 3 RASolute 302 trial Rolling submission of NDA for daraxonrasib to U.S. FDA under Commissioner’s National Priority

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Revolution Medicines

RAS(ON) Inhibitors Revolution Medicines develops oral targeted therapies that bind active, GTP-loaded RAS proteins. Its portfolio covers multiple RAS mutations and combination strategies across pancreatic and lung cancers. Daraxonrasib Daraxonrasib is a multi-selective RAS(ON) inhibitor and the company's lead late-stage asset. It has...

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