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News about "FDA Breakthrough Therapy Designation"
ArriVent's FURVENT Phase 3 Trial Misses Primary PFS Endpoint
ArriVent’s FURVENT Phase 3 trial of firmonertinib in EGFR exon 20 insertion-mutant NSCLC did not meet its primary PFS endpoint.
FDA Breakthrough Therapy Designation | 07/10/2026 | By News Bureau
Merck Wins US FDA Breakthrough Therapy Designation Status for Enpatoran in Lupus
Merck has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for enpatoran in lupus patients with active skin manifestations, advancing a potential first approved treatment for cutaneous lupus.
FDA Breakthrough Therapy Designation | 09/07/2026 | By News Bureau | 100
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