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Regeneron’s macular oedema therapy shows promise in Phase III trial
In the trial, subjects treated with the Eylea HD 8mg injection every eight weeks showed non-inferior visual acuity gains.
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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Linvoseltamab BLA Resubmission Accepted by FDA for Review
The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision ...
Regeneron Pharmaceuticals, Inc.: Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
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.
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Regeneron Pharmaceuticals' Linvoseltamab BLA Resubmission Accepted by FDA for Review in Relapsed/Refractory Multiple Myeloma
Regeneron Pharmaceuticals announced that the ... targets patients who have undergone multiple lines of therapy. The BLA is supported by data from the LINKER-MM1 trial, an ongoing study assessing ...
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FDA Sets Review Date for Linvoseltamab for Multiple Myeloma
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...
Investing $1,000 in These 3 Beaten-Down Stocks Could Be a Brilliant Move
Investing in stocks that aren't performing well can be a good move, but only if there are good reasons to think they will recover. That isn't the case for many companies that have lagged broader ...
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Linvoseltamab Under Review for Relapsed/Refractory Multiple Myeloma
Linvoseltamab is an investigational B-cell maturation antigen CD3-targeted bispecific antibody. The BLA resubmission was needed as the original application could not be approved due to manufacturing ...