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 ...

CytomX Therapeutics' innovative cancer therapies show promise with the CX-2051 and CX-801 trials. Explore the potential of ...

Q2 2025 Earnings Call Transcript August 8, 2025 Operator: Good afternoon, everyone. Thank you for standing by. Welcome to the ...

Of all the publicly traded companies on the S&P 500, just over 160 did not cite the effects of tariffs on their most recent ...

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.

Regeneron is having difficulties again with a contract manufacturer, reporting the delay of two FDA regulatory decisions due this month for Eylea.

Regeneron Q2 revenue rose 4% to $3.68 billion, driven by Dupixent and antibody profits, while FDA delays impacted Eylea HD and odronextamab approvals.

Regeneron Pharmaceuticals said issues at a contract manufacturer have resulted in regulatory setbacks for its Eylea HD eye drug and a proposed lymphoma drug. Regeneron on Friday said an expanded ...