Regeneron, which is seeking FDA approval of linvoseltamab for adults with relapsed/refractory multiple myeloma that has progressed after at least three prior therapies, said the agency set a new ...
Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals ... of Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July ...
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...
Regeneron (REGN) announced that the U.S. Food and Drug Administration has accepted for review the resubmission of the Biologics License ...
Biotech giant Regeneron Pharmaceuticals, Inc. REGN is slated to report fourth-quarter and full-year 2024 results on Feb. 4, 2025. The Zacks Consensus Estimate for fourth-quarter revenues is pegged ...
Regeneron reported Q4 2024 earnings today - revenues were up 10% YoY to $3.79bn. Full-year revenues were up 8% to $14.2bn. Q4 GAAP EPS at $8.06, and $38 adj. full-year. The company declared its ...
Regeneron Pharmaceuticals announced that the ... This acceptance follows the resolution of previously identified third-party fill/finish manufacturing issues. The FDA is expected to make a ...