BridgeBio Pharma Says FDA Has Granted Breakthrough Therapy Designation To Oral Infigratinib Under Development For Children With Achondroplasia
BridgeBio Pharma Says FDA Has Granted Breakthrough Therapy Designation To Oral Infigratinib Under Development For Children With Achondroplasia
bridgebio pharma表示，FDA已經授予其針對兒童骨發育不良症（Achondroplasia）正在研發的口服Infigratinib藥物突破性療法認定。
Breakthrough Therapy Designation is designed to expedite the development and regulatory review of drugs in the U.S. that meet stringent criteria.
突破性療法認定旨在加速符合嚴格標準的藥物在美國的開發和審評過程。
Drugs qualifying for this Designation must show preliminary clinical evidence that the drug may demonstrate a substantial improvement on clinically significant endpoints over available therapies.
符合該認定條件的藥物必須展示初步臨床證據，證明該藥物在臨床顯著終點上可能比現有治療方法有顯著改善。
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