The FDA approved tremelimumab (Imjudo, AstraZeneca) in combination with durvalumab, on 10/24/2022, for the treatment of unresectable hepatocellular carcinoma.
The FDA approved teclistamab (Tecvayli, Janssen), on 10/25/2022, for the treatment of relapsed or refractory multiple myeloma in patients who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. Teclistamab was approved with a boxed warning for Cytokine Release Syndrome (CRS) and Neurologic Toxicity.
The FDA rejected bulevirtide due to concerns regarding the manufacture and delivery of the drug.
The FDA accepted the NDA for quizartinib for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD positive and set a PDUFA date for 4/24/2023.
The FDA accepted the BLA for SER-109 for the prevention of recurrent C. difficile infection and set a PDUFA date for 4/26/2023.
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