A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when ...

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 complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve ...

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 ...