Ocugen, Kwangdong complete licensing agreement for OCU400 gene therapy in Korea
September 16th 2025Kwangdong, a top 5 pharmaceutical and healthcare company in Korea, is actively involved in research and development innovation, including “transformational late-stage, high-impact technologies.”
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Sandoz and Regeneron reach agreement over biosimilar dispute
September 10th 2025Sandoz received FDA approval for its biosimilar Enzeevu (aflibercept-abzv) on August 12, 2024. It has the same dosage form, route of administration, and presentation as the reference medicine, Eylea, from Regeneron.
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FDA extends target action date for two Regeneron regulatory submissions to Q4 of 2025
August 27th 2025Included is the supplemental Biologics License Application (sBLA) for EYLEA HD seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week dosing across approved indications.
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FDA clears IND for Opus Genetics’ OPGx-BEST1 gene therapy for inherited retinal disease
August 20th 2025Best disease, or vitelliform macular dystrophy, is a rare, inherited retinal condition causing macular degeneration by mutations in the BEST1 gene, leading to progressive vision loss and, in some cases, blindness.
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Lupin and Sandoz sign licensing deal for biosimilar ranibizumab across multiple regions
August 14th 2025Sandoz will oversee commercialization of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia under the terms of the agreement.
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