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Following the lifting of a clinical hold, the FDA has again accepted the BLA for tabelecleucel in adult and pediatric patients with EBV-positive PTLD.
FDA Accepts BLA, Grants Priority Review to Tab-Cel in EBV-Positive PTLD

July 28th 2025

Following the lifting of a clinical hold, the FDA has again accepted the BLA for tabelecleucel in adult and pediatric patients with EBV-positive PTLD.

Ibrutinib tablets will become available at 140 mg, 280 mg, and 420 mg for patients with chronic lymphocytic leukemia and Waldenstrom macroglobulinemia.
Generic Ibrutinib Tablets Earn Tentative FDA Approval in Blood Cancers

July 24th 2025

Many patients reported social/financial vulnerabilities that possibly precluded them from transplant access outside of the phase 2 clinical trial.
Cyclophosphamide-Based GVHD Prophylaxis May Improve Survival in HSCT

July 21st 2025

The FDA has asked tambiciclib’s developer to start a trial investigating the combination in front-line acute myeloid leukemia.
Tambiciclib Plus Ven/Aza Met All Primary End Points in R/R AML Trial

July 16th 2025

The FDA lifted a clinical hold on a new drug application for tabelecleucel as a treatment for EBV-positive lymphoproliferative disease in May 2025.
Developers Resubmit BLA for Tab-Cel in EBV+ Lymphoproliferative Disease

July 15th 2025

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