The FDA has issued a CRL regarding the sBLA for aflibercept 8mg injection for the addition of extended dosing intervals across all approved indications.

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 ...

Pharmaceuticals announced on Friday the Food and Drug Administration has issued a complete response letter regarding the ...

The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...

Swiss pharma giant Novartis (NOVN: VX) has announced a planned $23 billion investment over five years in US-based infrastructure, ensuring all key Novartis medicines for US patients will be made in ...

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in ...

In the United States, Regeneron maintains exclusive rights to aflibercept 2 mg (Eylea 2 mg) and aflibercept 8 mg (Eylea HD); outside the US, Bayer has licensed exclusive marketing rights. According to ...

Won-ho Joo, Head of the Naval & Special Ship Business Unit at HD Hyundai Heavy Industries, and Brian Schimpf, Co-Founder and CEO of Anduril, sign an MOU for the development and market entry of ...

When approaching the Fire HD 8 – with this version having launched in 2024 – it’s important to ask what you’re getting for your money, because this tablet is not only cheap at full price ...

Bkemv is being offered at 10% off Soliris, and Epysqli is offered at 30% below Soliris. Both biosimilars treat several of the same rare immune diseases as Soliris. Amgen’s Bkemv and Teva/Samsung ...

The results of a large randomized, quality improvement study in the US suggested that integrating large language model (LLM)-generated plain language summaries into ophthalmology notes can improve ...