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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.
This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit nascentmc.com
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