New FDA Approvals

Loqtorzi, Vabysmo, Omvoh, Vamorolone, Tibsovo, FluMist


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Check out our free downloads at nascentmc.com:

  • Implementing AMA Style – 8 Things to Get Right in Your Next Project
  • Needs Assessments – 7 Essentials for Getting Funded
  • Working With Your Medical Writer – 8 Ways to Get the Most out of Them

See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights:

·       Loqtorzi (toripalimab-tpzi) has received FDA approval for the treatment of nasopharyngeal carcinoma, both in combination with chemotherapy and as a monotherapy, demonstrating significant improvements in progression-free survival and overall survival.

·       Vabysmo (faricimab-svoa) has been approved by the FDA as a treatment for macular edema following retinal vein occlusion, showing early and sustained vision improvement in patients, with a generally well-tolerated safety profile.

·       Omvoh (mirikizumab-mrkz) has gained FDA approval for the treatment of moderate-to-severe active ulcerative colitis, offering a targeted approach to address inflammation in this chronic inflammatory bowel disease.

·       Agamree (vamorolone) oral suspension has been approved by the FDA as a novel corticosteroid treatment for Duchenne muscular dystrophy, demonstrating efficacy in improving muscle function with a favorable safety profile.

·       Tibsovo (ivosidenib) has received FDA approval for adult patients with relapsed/refractory myelodysplastic syndromes carrying an IDH1 mutation, offering a potential treatment option for this specific group.

·       The FDA is reviewing AstraZeneca's application to allow patients or caregivers to self-administer FluMist Quadrivalent, potentially becoming the first self-administered flu vaccine, with a decision expected in the first quarter of 2024. 

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New FDA ApprovalsBy Emma Hitt Nichols, PhD

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