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 ...

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

Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...

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

Inspection at Novo Nordisk unit Catalent delays action to Q4 2025, but investors keep faith in Eylea's outlook.

Nektar Therapeutics is fairly valued based on rNPV modeling, but multiple near-term catalysts could drive upside. Learn why ...

Biohaven (NYSE:BHVN) shares spiked in the premarket on Friday after the FDA revoked an advisory committee meeting scheduled ...