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Lantidra, Ngenla, Roctavian, Rystiggo, Skyclarys, Atorvaliq
Manage episode 407556917 series 3561458
Emma Nichols, PhD and Emma Hitt Nichols에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Emma Nichols, PhD and Emma Hitt Nichols 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from June 26 – June 30, 2023.
- Lantidra (donislecel-jujn) has been FDA approved for the treatment of type 1 diabetes. Lantidra is an allogeneic pancreatic islet cellular therapy derived from deceased donor pancreatic cells.
- Ngenla (somatrogon-ghla) has been approved by the FDA for the treatment of pediatric growth hormone deficiency. It is administered through weekly injections and is the second long-acting agent approved for use in children.
- Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy based on an adeno-associated virus vector, has received FDA approval for the treatment of severe hemophilia A in adults. It is administered as a one-time intravenous infusion.
- Rystiggo (rozanolixizumab-noli) has been granted FDA approval for the treatment of generalized myasthenia gravis (gMG) in adult patients who are positive for certain antibodies. It is a subcutaneous infusion of a humanized monoclonal antibody.
- Skyclarys (omaveloxolone) is the first FDA-approved treatment for Friedreich's ataxia. It is now available for patients aged 16 years and older.
- Atorvaliq (atorvastatin calcium) is the first FDA-approved liquid suspension of atorvastatin for the treatment of high cholesterol and risk factors for heart disease and stroke.
- Please check back every Monday morning for last week's approvals so that you can stay up to date.
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