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News about "FDA accelerated approval"
Gilead Sciences Wins FDA Accelerated Approval for First HDV Treatment Hepcludex
Gilead Sciences receives Food and Drug Administration (FDA) accelerated approval for Hepcludex, the first and only approved treatment for chronic Hepatitis Delta Virus (HDV), addressing a major unmet need in severe viral hepatitis care.
FDA Accelerated Approval | 26/05/2026 | By News Bureau
Regenxbio Reports Positive Pivotal Trial Results for Duchenne Gene Therapy RGX-202
Regenxbio’s investigational gene therapy RGX-202 demonstrated strong microdystrophin expression, functional gains and a favourable safety profile in Duchenne muscular dystrophy patients, supporting plans for accelerated approval and a potential commercial launch in 2027.
FDA Accelerated Approval | 15/05/2026 | By News Bureau
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