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The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.
Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea ...
Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval ...
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.
Investing.com -- Regeneron Pharmaceuticals, Inc. reported second-quarter earnings that significantly exceeded analyst expectations, with adjusted earnings per share reaching $12.89 compared to the ...
Regeneron has received a second complete response letter from the FDA for odronextamab and anticipates delays for Eylea HD due to inspection findings at a Novo Nordisk-owned manufacturing site, ...