The FDA has granted orphan drug designation to the oral agent OPN-6602 for the treatment of patients with relapsed or ...
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 ...
Genetic testing should be used to help doctors spot high-risk cases of myeloma and enable targeted treatments, say ...
Researchers sought to determine whether teclistamab would lead to a clinical response in patients with relapsed/refractory multiple myeloma.
The off-the-shelf chimeric antigen receptor T-cell therapy P-BCMA-ALLO1 was shown to be safe and elicited strong anti-tumor ...
Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision ...
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...
In the phase 3, randomized CARTITUDE-4 trial involving patients with lenalidomide-refractory multiple myeloma who had received one to three previous lines of therapy, cilta-cel significantly ...
Hong Kong Department of Health accepts IASO Bio’s NDA for equecabtagene autoleucel to treat r/r multiple myeloma: Shanghai, Nanjing Monday, February 17, 2025, 17:00 Hrs [IST] IA ...
Antengene’s Xpovio approved for reimbursement in Taiwan to treat adult patients with relapsed/refractory multiple myeloma: Shanghai Friday, February 14, 2025, 16:00 Hrs [IST] An ...
an investigational treatment for adult patients with relapsed/refractory multiple myeloma. This acceptance follows the resolution of previously identified third-party fill/finish manufacturing issues.
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