Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...

Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.

Regeneron (REGN) announced that the U.S. Food and Drug Administration has accepted for review the resubmission of the Biologics License ...

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 ...

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 ...

(RTTNews) - Regeneron Pharmaceuticals ... The BLA acceptance follows resolution of third-party fill/finish manufacturing issues identified by the FDA in the previous submission.

Q4 2024 Earnings Call Transcript February 4, 2025 Operator: Hello, and welcome to Regeneron Pharmaceuticals Fourth Quarter ...

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 ...

Regeneron does not undertake any obligation ... a changing product mix as well as ongoing start-up costs for our new fill/finish facility and investments to drive future efficiencies across ...

The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician ...