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.
Astra’s Neogene investment nosedives
NT-125 is discontinued, while two key Datroway readouts are delayed.
FDA rejects Replimune’s oncolytic virus
There are questions about vuso-vec’s supporting and confirmatory trials.
Columvi avoids its worst-case scenario
Roche’s drug is knocked back in second-line lymphoma, but keeps its third-line nod.
Adcom puts up a Blenrep roadblock
A surprising no to both multiple myeloma uses puts the ball in the FDA's court.
The FDA's "radical transparency", up to a point
A newly published cache of CRLs includes six novel oncology drugs.
More problems for BioNTech & Roche’s neoantigen shot
Autogene cevumeran goes on hold in adjuvant bladder cancer.
