Regeneron gets FDA acceptance to review expanded label for Eylea HD Apr. 17, 2025 9:17 AM ET Regeneron Pharmaceuticals, Inc. (REGN) Stock , BAYZF Stock , BAYRY Stock By: Nilanjana Basu , SA News ...

High-dose Eylea, or aflibercept 8 mg, is being jointly developed by Regeneron and Bayer AG. Regeneron shares were down 1.3% Tuesday before being halted in advance of the news. About the Author ...

TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response ...

Bayer's global product strategy and commercialisation lead, Christine Roth, said that the new label means that Eylea 8mg "has the potential to establish a new standard of care for retinal diseases." ...

FDA accepts Regeneron's sBLA for Eylea HD in RVO with priority review; QUASAR data supports monthly dosing, target action date set for August 2025.

The treatment is a biosimilar that could compete with Regeneron Pharmaceuticals’ Eylea. Teva and Alvotech have been working together in a strategic partnership since 2020.

TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response ...

Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 treatment for eye disorders, which could compete with Regeneron ...