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Lantidra, Ngenla, Roctavian, Rystiggo, Skyclarys, Atorvaliq
Manage episode 407556917 series 3561458
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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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