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FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia

March 27th 2024

Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.

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FDA Issues Complete Response Letter to Regeneron’s Odronextamab Based on Confirmatory Trial Enrollment Status

March 25th 2024

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Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma

March 19th 2024

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FDA Lifts Partial Clinical Hold on Phase II Trial of Novel Tumor Infiltrating Lymphocyte Cell Therapy for NSCLC

March 5th 2024

Image credit: Lisa | stock.adobe.com. High grade follicular lymphoma with marginal zone differentiation. Multiple lymphocytes are undergoing mitosis. Microscopic view.
FDA Grants Priority Review to Epkinly for Follicular Lymphoma Based on Data From Phase I/II EPCORE NHL-1 Trial

February 27th 2024

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