Regeneron Gets New FDA Review of Linvoseltamab for Multiple Myeloma
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 ...
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Regeneron Pharmaceuticals' Linvoseltamab BLA Resubmission Accepted by FDA for Review in Relapsed/Refractory Multiple Myeloma
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 ...
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Regeneron Pharmaceuticals, Inc. (REGN)
While Regeneron Pharmaceuticals, Inc. ( NASDAQ:REGN ) shareholders are probably generally happy, the stock hasn't had... Acceptance follows resolution of third-party fill/finish manufacturing ...
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Regeneron Pharma Says FDA Accepted BLA For Linvoseltamab To Treat Multiple Myeloma
(RTTNews) - Regeneron Pharmaceuticals ... The BLA acceptance follows resolution of third-party fill/finish manufacturing issues identified by the FDA in the previous submission.
Regeneron announces FDA acceptance of BLA for linvoseltamab
Regeneron (REGN) announced that the U.S. Food and Drug Administration has accepted for review the resubmission of the Biologics License ...
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
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Regeneron Gets New FDA Review of Linvoseltamab for Multiple Myeloma
Regeneron on Tuesday said the FDA's acceptance follows the resolution of its third-party fill/finish manufacturing issue, which was the sole issue the agency identified when it turned away the ...