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New treatments for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) enhance patient care with gene therapies and new mechanisms of action on the horizon, explained ...
The company announced 27 abstracts at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting ...
After 3 initial monthly injections, current dosing intervals range from every 8 to 16 weeks in patients with wAMD and DME and every 8 to 12 weeks in patients with DR.
UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to slow, halt, or reverse ...
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...
In this expert perspective, Manjot K. Gill, MD, discusses the potential FDA approval in 2025 of aflibercept 8 mg for the treatment of retinal vein occlusion.
The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...
The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License ...
Patients with diabetic macular edema treated with intravitreal aflibercept have a significantly higher risk of adverse renal events compared with those treated with ranibizumab.
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FDA to review Regeneron’s sBLA for aflibercept injection 8mgThe US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...
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