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Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea ...
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 ...
Inspection at Novo Nordisk unit Catalent delays action to Q4 2025, but investors keep faith in Eylea's outlook.
Regeneron Pharmaceuticals ( NASDAQ: REGN) announced that the U.S. FDA has extended the target action dates for two regulatory ...
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TipRanks on MSNRegeneron says FDA delayed review of two Eylea HD submissions
Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...
The FDA issued a Complete Response Letter for Regeneron’s biologics license application for odronextamab, a bispecific antibody targeting CD20 and CD3 for the treatment of relapsed or refractory ...
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 ...
Regeneron is having difficulties again with a contract manufacturer, reporting the delay of two FDA regulatory decisions due this month for Eylea.
REGENERON PHARMACEUTICALS (REGN): Free Stock Analysis Report This article Regeneron's Pipeline Hit By Catalent Delays, But Dupixent Shines originally appeared on Benzinga.com ...
TARRYTOWN, N.Y. (AP) — TARRYTOWN, N.Y. (AP) — Regeneron Pharmaceuticals Inc. (REGN) on Friday reported second-quarter earnings of $1.39 billion.
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