The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
FDA Grants Pembrolizumab Sixth Indication in NSCLC
October 17th 2023The anti–PD-1 agent pembrolizumab was granted a new indication to treat patients with resectable non–small cell lung cancer (NSCLC) as a neoadjuvant treatment with chemotherapy and continued as adjuvant treatment after surgery.
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First Tocilizumab Biosimilar Approved in the United States
October 5th 2023The FDA has approved Tofidence, the first tocilizumab biosimilar in the United States, which will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
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Dr Javed Butler Highlights Positive Outcomes, Important Lessons From HEART-FID
September 19th 2023Javed Butler, MD, MPH, MBA, professor of medicine at University of Mississippi, president of the Baylor Scott & White Research Institute, explains how findings from the HEART-FID trial add to the value of ferric carboxymaltose injection.
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FDA Approves Elranatamab for Relapsed or Refractory Multiple Myeloma
August 14th 2023The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
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