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News about "US FDA acceptance"
US FDA Accepts Roche's Lunsumio-Polivy Filing for Relapsed Large B-Cell Lymphoma
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application for the Lunsumio and Polivy combination in relapsed or refractory large B-cell lymphoma. The filing is supported by Phase 3 SUNMO study data showing a 59 percent reduction in the risk of disease progression or death.
US FDA Acceptance | 19/06/2026 | By News Bureau | 101
Bristol Myers Squibb Secures FDA Priority Review for Camzyos
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s supplemental New Drug Application (NDA) for Priority Review (PR) of Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
US FDA Acceptance | 02/06/2026 | By News Bureau | 105
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