erdafitinib
FDA Grants Full Approval to Janssen's Balversa in Narrower FGFR-Altered Bladder Cancer Indication
The full approval narrowed the accelerated approval indication to only bladder cancer patients harboring susceptible FGFR3 alterations.
J&J Oncology Revenues Jump 12 Percent in Q3
The firm touted sales gains for Carvykti and highlighted regulatory updates for Akeega, Balversa, and Rybrevant in Q3.
Janssen Seeks Full Approval for Balversa in FGFR3-Altered Bladder Cancer
The firm submitted data from cohort 1 of the Phase III THOR trial, showing Balversa improved survival and response rates versus standard-of-care chemo.