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Review top news and interview highlights from the week ending November 28, 2025.

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

The FDA also added a new Warnings & Precaution for heightened susceptibility to serious infections caused by immunosuppression.

According to Novartis, it is the first gene replacement therapy to have been approved “for this broad population.”

Review top news and interview highlights from the week ending November 21, 2025.

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

According to Intellia, the FDA placed clinical holds on both MAGNITUDE and MAGNITUDE-2 on October 29, 2025.

Review top news and interview highlights from the week ending November 7, 2025.

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

Naji Gehchan, MD, MBA, the chief medical and development officer of Kyverna Therapeutics, went over new data the company presented at AANEM’s 2025 meeting.

uniQure pointed out that this new feedback stands in contrast to its previous communications with the FDA in several Type B meetings.

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

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 October 31, 2025.

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

The patient showed grade 4 liver transaminases and increased total bilirubin and was hospitalized.

Review top news and interview highlights from the week ending October 24, 2025.

Deborah Phippard, PhD, and Renier Brentjens, MD, PhD, discussed their thoughts on major moments in the past 25 years of cell and gene therapy research.

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

The primary end point of the study was met.

Review top news and interview highlights from the week ending October 17, 2025.

Headaches, falls, and nausea constituted the common treatment-emergent AEs, and were deemed mild-to-moderate in terms of severity.

Tr1X intends to go forward with plans for a phase 1/2a dose-escalation clinical trial, which it expects to launch early next year.

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

With regard to safety, MYR-101 was characterized as “well tolerated” with a “favorable safety profile.”



























































