The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision ...

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

The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with 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 ...

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

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, 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 ...

RxTechExam and the Pennsylvania Pharmacists Association announced a strategic partnership. Roche’s $8 billion InterMune acquisition has been handed to a specialty pharmaceutical company, Cayman ...

Regeneron has moved closer to a regulatory filing for its BCMAxCD3 bispecific antibody linvoseltamab, the first of a series of bispecifics that is spearheading its oncology pipeline. New data from ...

Regeneron, meanwhile, is also not far from filing for approval of its linvoseltamab bispecific in heavily pretreated patients and is running the LINKER-MM3 study in patients who have received ...

Suzanne Lentzsch, MD, PhD, of Columbia University, presented promising results of linvoseltamab for treating relapsed/refractory multiple myeloma (RRMM) at the European Hematology Association 2024 ...

for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least fo Investing in stocks that aren't performing well can be a ...