New FDA Approvals

Lantidra, Ngenla, Roctavian, Rystiggo, Skyclarys, Atorvaliq


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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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New FDA ApprovalsBy Emma Hitt Nichols, PhD

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