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Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.

Review top news and interview highlights from the week ending August 29, 2025.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Prerna Mewawalla, MD, the medical director of Apheresis and a hematologist-oncologist in the Division of Hematology and Cellular Therapy at Allegheny Health Network, spoke on unmet needs in patients who receive early-line CAR-T for R/R MM.

Surbhi Sidana, MD, the assistant professor of medicine, bone marrow transplantation, and cellular therapy at Stanford discussed the benefit of second-line cilta-cel in PFS and OS.

Review top news and interview highlights from the week ending August 22, 2025.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Review top news and interview highlights from the week ending August 15, 2025.

The complete response rate was 88%.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The RMAT designation was granted based on data from the phase 1/2 ATALANTA-1 clinical trial, which includes a subset of patients with R/R MCL.

The move was based on updated safety data from an FDA probe into the risk of hematologic malignancies in patients treated with eli-cel.

The hematologist/oncologist at the University of Pittsburgh Medical Center Hillman Cancer Center in Pennsylvania discussed updates to NCCN guidelines and research to pay attention to in hematologic malignancies.

Review top news and interview highlights from the week ending August 8, 2025.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The Prescription Drug User Fee Act goal date for the sBLA has been set for December 5, 2025.

The patient’s death was attributed to anti-CD52 monoclonal antibody ALLO-647 rather than to cema-cel itself.

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.

Review top news and interview highlights from the week ending August 1, 2025.

Notably, the BLA resubmission was accepted with priority review and the PDUFA target action date has been set for January 10, 2026.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Review top news and interview highlights from the week ending July 25, 2025.

The therapy was approved based on findings of the pivotal phase 1b/2 FELIX clinical trial.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Review top news and interview highlights from the week ending July 18, 2025.