FDA Approves BeOne Medicines’ Beqalzi for Relapsed/Refractory Mantle Cell Lymphoma

BeOne Medicines has received FDA approval for Beqalzi in relapsed or refractory mantle cell lymphoma. U.S. Beqalzi is a BCL-2 inhibitor and becomes the latest drug approved for this indication.

Beqalzi's clearance provides a new targeted option for patients with this form of lymphoma who have relapsed or become refractory to prior treatments. Separately on the same day, CREATE Medicines raised $122 million to advance its in vivo CAR-T for autoimmune disease into the clinic. The financing underscores continued investor interest in expanding cell therapy applications beyond oncology.

Biotech Correspondent Meghana Keshavan covers biotech and contributes to The Readout newsletter. The article detailing these developments appeared on May 14, 2026. @statnews reported on both the BeOne Medicines approval and the CREATE Medicines financing within its May 14, 2026 edition of The Readout.

The newsletter also noted that the Trump administration is searching for a new FDA commissioner. CREATE Medicines' $122 million raise specifically aims to move its in vivo CAR-T program into clinical testing for autoimmune indications.

Meghana Keshavan wrote the coverage for STAT. Her reporting highlighted the expansion of cell therapy approaches into new disease areas while also tracking regulatory developments at the FDA.