Vadadustat FDA:Akebia says FDA will give its once

Akebia says FDA will give its once

Akebia says FDA will give its once

2023年5月30日—TheFDArejectedvadadustatbecauseoftheriskofheartproblemsaswellasdrug-inducedliverdamage.Duringtheappealprocess,thecompany ...。其他文章還包含有:「Afterhigh」、「AkebiaproposesnewdosingfororalanemiadrugamidFDA...」、「AkebiaTherapeuticsCompletedTypeAMeetingwiththeFDA...」、「FDAProvidesAkebiaTherapeuticsaPath...」、「FDAProvidesAkebiaTherapeuticsaPathForwardfor...」、「FDA拒絕批准...

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After high
After high

https://www.fiercepharma.com

Akebia plans to resubmit its application for vadadustat for anemia due to chronic kidney disease in adult patients on dialysis by the end of the ...

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Akebia proposes new dosing for oral anemia drug amid FDA ...
Akebia proposes new dosing for oral anemia drug amid FDA ...

https://www.fiercepharma.com

Vadadustat belongs to an emerging class of drugs known as HIF-PHI. The class once bore high hopes as potentially convenient alternatives to ESAs ...

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Akebia Therapeutics Completed Type A Meeting with the FDA ...
Akebia Therapeutics Completed Type A Meeting with the FDA ...

https://www.prnewswire.com

Vadadustat is approved in Europe for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis. In Japan, ...

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FDA Provides Akebia Therapeutics a Path ...
FDA Provides Akebia Therapeutics a Path ...

https://www.biospace.com

Vadadustat is approved in Europe for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis. In Japan, ...

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FDA Provides Akebia Therapeutics a Path Forward for ...
FDA Provides Akebia Therapeutics a Path Forward for ...

https://ir.akebia.com

Vadadustat is approved in Europe for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis. In Japan ...

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FDA 拒絕批准貧血藥物Vadadustat,Akebia 大規模裁員
FDA 拒絕批准貧血藥物Vadadustat,Akebia 大規模裁員

https://geneonline.news

美國食品藥物管理局(FDA)因為安全問題近期拒絕批准美國生物製藥公司Akebia Therapeutics 用於治療慢性腎病引起的貧血藥物Vadadustat,因其增加了 ...

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Press Release
Press Release

https://ir.akebia.com

Vadadustat is an investigational new drug and is not approved by the U.S. Food and Drug Administration (FDA). On March 29, 2022 , the FDA issued a complete ...

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《FDA》不服慢性腎病貧血藥物Vadadustat藥證申請遭拒 ...
《FDA》不服慢性腎病貧血藥物Vadadustat藥證申請遭拒 ...

http://www.genetinfo.com

Akebia Therapeutics旗下治療慢性腎病貧血藥物Vadadustat因安全性問題於今年3月遭FDA拒絕新藥申請(NDA),公司近日已向FDA提出正式爭議解決需求(FDRR) ...

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《FDA》安全問題! 美國FDA 拒絕批准Akebia 慢性腎病貧血藥 ...
《FDA》安全問題! 美國FDA 拒絕批准Akebia 慢性腎病貧血藥 ...

http://www.genetinfo.com

據了解,在該試驗中,雖然使用vadadustat 的患者比使用對比藥物的患者出現了更多的血栓栓塞事件,但總體事件發生率是相同的─ 都是6.6 人/100 患者年( ...