FDA red and green lights: July 2025
Approvals come for Regeneron and Dizal, but Roche and Replimune see knockbacks.
Bristol seeks another celmod use
Golcadomide will begin a new pivotal trial in follicular lymphoma.
Regeneron’s lung cancer Lag3 lag
Fianlimab NSCLC data are delayed, while odronextamab gets a DLBCL blow.
Regeneron gets a European reprieve
The EU recommendation for odronextamab comes after a US rejection in March.
FDA green and red lights: June 2024
Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.
FDA knocks back Regeneron’s CD20 T-cell engager
The decision highlights the fact that Regeneron is still doing dose-finding work for odronextamab.
