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AEON Biopharma Says Is Aligned With FDA On Next Steps For 351(k) Regulatory Pathway To Approval For ABP-450 As A Biosimilar Utilizing BOTOX As The Reference Product

AEON Biopharma Says Is Aligned With FDA On Next Steps For 351(k) Regulatory Pathway To Approval For ABP-450 As A Biosimilar Utilizing BOTOX As The Reference Product

AEON生物製藥表示,與FDA在ABP-450作爲生物類似藥物,採用BOTOX作爲參比品的351(k)監管途徑獲得批准的下一步工作取得一致。
Benzinga ·  09/30 20:05

AEON Biopharma Says Is Aligned With FDA On Next Steps For 351(k) Regulatory Pathway To Approval For ABP-450 As A Biosimilar Utilizing BOTOX As The Reference Product

AEON生物製藥表示,與FDA在ABP-450作爲生物類似藥物,採用BOTOX作爲參比品的351(k)監管途徑獲得批准的下一步工作取得一致。

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