Bristol Myers Squibb Co., BMY, FDA Calendar, PDUFA Date

Company Name	Bristol Myers Squibb Co. BMY
Drug Name	Breyanzi (sBLA)
Event Name	FDA decision to expand the use of Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma
Event Date	12/05/2025
Outcome Date	12/04/2025
Outcome	FDA approved Breyanzi for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy on Dec.4, 2025
Drug Status	Priority Review
Rival Drugs
Market Potential
Other Approvals	Breyanzi is already approved in the U.S. for the treatment of Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma, and Mantle Cell Lymphoma
News

Return to FDA Calendar

Slide Shows