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Regenerative Medicine Advanced Therapy

PharmaDeviceNews Regenerative Medicine Advanced Therapy
Representative image: An ophthalmology team reviews retinal scans as Ocugen’s $OCGN OCU410 one-time gene therapy receives FDA RMAT designation ahead of a Phase 3 geographic atrophy trial.
Pharma & Biotech

FDA grants RMAT designation to OCU410 after Phase 2 geographic atrophy results

OCU410 receives FDA RMAT designation after Phase 2 data showed 31% slower geographic atrophy lesion growth with one gene therapy dose.

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AbelZeta’s FDA-cleared registrational Phase II trial will evaluate the investigational dual-target CAR-T therapy C-CAR168 in patients with refractory lupus nephritis. Representative image.
Pharma & Biotech

Can AbelZeta turn a tiny lupus dataset into a registrational CAR-T breakthrough?

AbelZeta's FDA-cleared Phase II C-CAR168 trial tests whether dual-target CAR-T can deliver durable renal responses in refractory lupus nephritis.

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