FDA extends target action date for two Regeneron regulatory submissions to Q4 of 2025
August 21st 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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Lupin and Sandoz sign licensing deal for biosimilar ranibizumab across multiple regions
August 13th 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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4DMT accelerating 4D-150 4FRONT phase 3 program, laying off 25% of staff
July 7th 2025The company notes that the workforce reduction is expected to provide annual cash compensation cost savings of approximately $15 million and offsets additional expenses expected based on the accelerated timelines for the 4FRONT clinical trials.
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Valorum Biologics to commercialize Formycon’s Eylea Biosimilar FYB203 in US and Canada
June 26th 2025FYB203 has been approved by the US FDA and UK Medicines and Healthcare products Regulatory Agency for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema, macular edema following retinal vein occlusion, and visual impairment due to myopic choroidal neovascularization.
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