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News about "Fast Track Designation (FTD)"
US FDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy
The US Food and Drug Administration (FDA) has approved Isembyld, the first therapy for Spinal Muscular Atrophy (SMA) that directly targets muscle loss alongside existing treatments.
Fast Track Designation (FTD) | 14/09/2026 | By News Bureau | 107
GSK to Advance mRNA Seasonal Flu Vaccine Candidate to Phase 3
GSK advances its mRNA seasonal flu vaccine to phase 3 after positive phase 2 data showed higher immune responses versus standard and high-dose vaccines.
Fast Track Designation (FTD) | 02/09/2026 | By News Bureau | 122
Argo Biopharma's siRNA Therapy BW-20805 Gets FDA Fast Track for HAE
Argo Biopharma has received FDA Fast Track designation for BW-20805, with an ongoing global phase-II study in adult HAE patients and primary completion expected in the second half of 2026.
Fast Track Designation (FTD) | 17/03/2026 | By News Bureau | 184
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