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Notably, the European Medicines Agency also granted MCO-010 orphan drug designation for 5 retinal dystrophy categories.

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

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.

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.

Notably, the first patient was dosed in the GARDian3 in July 2025.

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

AAVB-039 is intended to deliver a functional copy of the disease-targeted ABCA4 gene.

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.

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.

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.

Ocugen initiates pivotal confirmatory trial for OCU410ST, its second modifier gene therapy candidate, in patients with Stargardt disease.

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.

Atsena Therapeutics will advance ATSN-201 into a pivotal phase 1/2/3 trial following FDA agreement on study design and endpoints.

The CGTLive® team highlights 5 therapeutics that are nearing major decisions by the FDA.

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

According to the company, the BLA is the first for a gene-agnostic gene therapy for retinal disease to have been submitted to the FDA.

Review top news and interview highlights from the week ending July 11, 2025.