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Regeneron

The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Shots:Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19,…

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Top Performing Drug of 2021 – Eylea (September Edition)

Top Performing Drug of 2021 – Eylea (September Edition)

Active Ingredient: AfliberceptStrength: 2 mg (0.05 mL)Dosage Form: Injection (intravitreal)Mechanism of Action: VEGF-A and PlGF inhibitorsFirst Approval: US (18 Nov 2011), EU (27 Nov 2012)Revenue1EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in…

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