News

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

We highlighted a few cell and gene therapies that are nearing or likely nearing key FDA decisions in the first half of 2026.

Colleen Caleshu, MS, CGC, the senior director of research and real world data at Genome Medical, discussed important considerations for genetic counselors thinking about using AI tools in their practice.

The BLA is supported by 96-week data from the randomized, placebo-controlled phase 3 GlucoGene clinical trial.

Deborah Phippard, PhD, and Renier Brentjens, MD, PhD, spoke about the potential of AI to affect development and use of cell and gene therapy products.

Take a look what stood out as pillars of progress and success from all of CGTLive's most popular oncology stories in 2025.

In this bonus episode of ImmunoLogic, the hosts discussed highlights from 2025, including some covered in previous episodes of the series.

Deborah Phippard, PhD, shared her thoughts with Renier Brentjens, MD, PhD, on cost reduction for cell and gene therapy products.

Deborah Phippard, PhD, and Renier Brentjens, MD, PhD, discussed their thoughts on the field's future.

In this bonus episode of ImmunoLogic, the hosts discussed immunotherapy highlights from ASH's annual meeting.

The trial is open to patients with a wide array of solid tumor indications.

Review top news and interview highlights from the week ending December 19, 2025.

The rolling BLA is supported by data from the phase 1/2 STAAR clinical trial (NCT04046224).

Steven W. Pipe, MD, a professor of pediatric hematology/oncology at the University of Michigan Health, also discussed open questions that remain for the future of the hemophilia B gene therapy.

The genetic counselor at Johns Hopkins Hospital spoke on how cardiac genetics clinics are adopting alternative care models to broaden access to genetic testing and counseling.

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

Deborah Phippard, PhD, shared her thoughts with Renier Brentjens, MD, PhD, on the importance of big wins for those in research.

The professor of pediatric hematology/oncology at the University of Michigan Health also discussed open questions that remain for the future of the hemophilia B gene therapy.

The chairman of the Division of Pediatric Hematology & Oncology and BMT at Cleveland Clinic Children's discussed learnings from the institutions integration of gene therapy for sickle cell disease.

Steven W. Pipe, MD, a professor of pediatric hematology/oncology at the University of Michigan Health, discussed the final results of the phase 3 study that evaluated the hemophilia B gene therapy.

Rabi Hanna, MD, the chairman of the Division of Pediatric Hematology & Oncology and BMT at Cleveland Clinic Children's, discussed results from the phase 1/2 RUBY trial.

Review top news and interview highlights from the week ending December 12, 2025.

Sharon Hesterlee, PhD, the president and CEO of the Muscular Dystrophy Association, discussed the upcoming conference and the evolving therapeutic landscape in neuromuscular disease.

The professor of pediatric hematology/oncology at the University of Michigan Health discussed the final results of the phase 3 study that evaluated the hemophilia B gene therapy.

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

The Fondazione Telethon agent, etuvetidigene autotemcel, significantly reduced severe infections and bleeding events in clinical studies.

Deevyashali Parekh, MBBS, an internal medicine resident at SUNY Upstate Medical University Hospital, discussed findings from a patient population traditionally excluded from clinical trials for CAR-T.

The chairman of the Division of Pediatric Hematology & Oncology and BMT at Cleveland Clinic Children's discussed results from the phase 1/2 RUBY trial he presented at ASH 2025.