FDA Approvals

LYNOZYFIC is now approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

Learn More

Pfizer Oncology is pleased to share that on July 11, 2025, the FDA approved a less frequent dosing option for certain responding patients being treated with ELREXFIO® (elranatamab-bcmm).  ELREXFIO is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

Learn More

Astellas Pharma US, Inc. is pleased to announce the U.S. Food and Drug Administration (FDA) approval of a 300 mg vial size (NDC: 0469-4425-30) for VYLOY Ò
(zolbetuximab-clzb) in addition to its current 100 mg vial size (NDC: 0469-3425-10).

For more information, please visit VyloyHCP.com.

Please click here for the full Prescribing Information.

For important state pricing disclosure information, click here.

Learn More

U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels

Learn More

Coding and Reimbursement Updates

Bobbi Buell’s E-Reimbursement newsletter for July is now available online. It includes an update on The Proposed Medicare Part B Rules 2026, OPPS Proposal for 2026

Learn More