Despite boasting a new owner, the Indiana manufacturing plant that Novo Nordisk picked up as part of its parent company's ...

The FDA has identified critical lapses at a production facility operated by Novo Nordisk that is used by several drugmakers, ...

Regeneron Pharmaceuticals faced a setback as the FDA postponed its decision on EYLEA HD's approvals to late 2025. This delay ...

Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea ...

The FDA extends action dates for Regeneron's Eylea HD filings following inspection findings at Catalent Indiana. Nonetheless, Eylea HD remains available through vial administration.

The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.

Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval ...

The hits just keep on coming for Regeneron’s Eylea franchise. | The FDA has extended its target action dates for two ...

Regeneron Pharmaceuticals ( NASDAQ: REGN) announced that the U.S. FDA has extended the target action dates for two regulatory ...

Regeneron Pharmaceuticals, Inc. (REGN) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has extended ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® ...