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Monday, July 14, 2025

Tag: retinal disease

Nanoscope Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for MCO-010, the First Gene-Agnostic Therapy to Treat Retinitis Pigmentosa

First modules of BLA submitted to FDA under rolling review, with full submission anticipated in early 2026MCO-010 BLA for retinitis pigmentosa is eligible for priority review...

Atsena Therapeutics Announces Alignment with FDA on Regulatory Pathway to Approval for ATSN-201 in X-Linked Retinoschisis (XLRS)

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval

- A word from our sponsors -

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