FDA red and green lights: August 2025
Boehringer’s Hernexeos beats Bayer’s sevabertinib to the US.
FDA doubles down on overall survival
New draft guidance could see the agency getting ever stricter.
BioNTech quietly drops Claudin6 work
A phase 2 trial of the Car-T project BNT211 is withdrawn just months after it began.
More delays for Regeneron
The company gets another odronextamab knockback, while a key fianlimab readout is postponed.
FDA red and green lights: July 2025
Approvals come for Regeneron and Dizal, but Roche and Replimune see knockbacks.
