- Under accelerated review status, the FDA approves Johnson & Johnson (NYSE:JNJ +0.2%) unit Janssen Biotech's Balversa (erdafitinib) for the treatment of adult patients with locally advanced/metastatic bladder cancer with FGFR3 or FGFR2 mutations who have progressed during or following prior platinum-based chemotherapy.
- Immunomedics (NASDAQ:IMMU +0.4%) will will provide detailing services per a recent agreement.
- The agency also approved QIAGEN's (NYSE:QGEN -0.8%) companion diagnostic for use in screening appropriate patients for Balversa.