FDA red and green lights: August 2025
Boehringer’s Hernexeos beats Bayer’s sevabertinib to the US.
Ivonescimab back in tune
China's Harmoni-A trial hits on overall survival, but hopes for a global phase 3 seem optimistic.
Otsuka zips into adjuvant use
As a second-line zipalertinib filing approaches, Otsuka goes earlier and broader.
Bristol takes its bispecific conjugate into lung cancer
A second global pivotal trial will test iza-bren in the same NSCLC setting where patri-dxd failed.
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.
Bristol pulls ahead of Amgen
The company will start a phase 2/3 trial of its Mirati-originated PRMT5 inhibitor in autumn.
