CGTLive

Ocugen Doses First Patient in Phase 3 Trial of OCU410 for GA

Ocugen dosed the first patient in ArMaDa3, a global phase 3 trial of the one-time gene therapy OCU410 for geographic atrophy, following FDA RMAT designation and phase 2 data showing a 31% reduction in ...
CGTLive

Novartis, BMS Pause Autoimmune CAR-T Trials After Safety Events

Novartis suspended several autoimmune and neurology trials of rap-cel after 3 patient deaths linked to immune effector cell-associated hemophagocytic syndrome, and BMS separately paused zola-cel ...
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First Patient Dosed in Phase 3 Trial for Intellia Therapeutics’ Hereditary Angioedema Gene Editing Therapy NTLA-2002

The company stated it expects to submit a BLA to the FDA next year. The first patient has been dosed in Intellia Therapeutics’ pivotal phase 3 HAELO clinical trial (NCT06634420) evaluating NTLA-2002, ...
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Robert J. Hopkin, MD, on Looking Deeper into Fabry Disease Biology

The associate professor of clinical pediatrics at Cincinnati Children's discussed further investigations into novel therapies and new research. “We know that the stored material causes problems. But ...
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FDA Activity Recap: December 2025 Features Multiple Approvals, RMAT Designation, and More

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team. Last month, December 2025, the CGTLive ® team was diligently tracking the ...
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Marcela Maus, MD, PhD, on New Approaches to CAR T-Cell Therapy for Solid Tumors

The Associate Professor of Medicine at Harvard Medical School discussed upcoming research and strategies to combat present hurdles in the treatment field. “I think that there's a lot of interesting ...
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Top FDA Gene and Cell Therapy News: 2025 Year-End Recap

Recapping some the FDA approvals and regulatory updates in cell and gene therapy that made waves in 2025. As 2025 comes to a close, CGTLive has looked back on some of the most-read and most impactful ...
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FDA Activity Recap: July 2025 Features Multiple CRLs, RMAT Designation, and More

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team. Last month, July 2025, the CGTLive ® team was diligently tracking the FDA's ...
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ASGCT’s Q4 2024 Landscape Report Indicates Steady Rate of Growth

David Barrett, JD, the chief executive officer of ASGCT, broke down the highlights of the organization’s final report for 2024. Each quarter, the American Society of Gene & Cell Therapy (ASGCT) puts ...
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FDA Approves bluebird bio's Lovo-Cel Gene Therapy for Sickle Cell Disease

Approved for sickle cell disease with a history of vaso-occlusive events in patients 12 and older. Carries a boxed warning for hematologic malignancy with long-term monitoring. Commercially available ...
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Intellia Puts Phase 3 Trials for Transthyretin Amyloidosis Gene Editing Therapy Nex-Z on Hold Following Grade 4 Liver AE

The patient showed grade 4 liver transaminases and increased total bilirubin and was hospitalized. Intellia has temporarily paused dosing and screening of patients for both the phase 3 MAGNITUDE ...
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FDA Activity Recap: September 2025 Features New Draft Guidance Documents, RMAT Designation, and More

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team. Last month, September 2025, the CGTLive ® team was diligently tracking the ...