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Cullinan's Zipalertinib Combination Heads To FDA After Positive Phase 3 Lung Cancer Trial
Source: Nasdaq
Healthcare & BiotechRegulation & LegislationProduct Launches
Cullinan Therapeutics initiated submission of a U.S. FDA New Drug Application for zipalertinib combined with platinum-based chemotherapy as a first-line treatment for patients with EGFR exon 20 insertion-mutant disease. The filing marks a significant regulatory milestone that could expand Cullinan's commercial opportunity, subject to FDA acceptance and approval.
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