Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use ...

Regeneron’s bid to join the market for BCMA-targeted bispecific antibodies for multiple myeloma is nearing a conclusion, with the FDA starting a priority review of its linvoseltamab drug candidate.

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site.

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 ...

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...

The European Commission is anticipated to make its final decision on the conditional marketing authorization for linvoseltamab in the forthcoming months. The CHMP's favorable stance is based on ...

The European Commission is anticipated to make its final decision on the conditional marketing authorization for linvoseltamab in the forthcoming months. The CHMP’s favorable stance is based on ...