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 ...

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

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 ...