FDA knocks back Regeneron’s CD20 T-cell engager
The decision highlights the fact that Regeneron is still doing dose-finding work for odronextamab.
Ascentage’s Venclexta challenge looks wildly optimistic
A just revealed clinical trial listing shows Ascentage’s BCL-2 inhibitor being compared against an outdated standard of care.
Iclusig comes too late to rescue Takeda
The drug adds a new use to its US label, but Takeda’s 2017 Ariad acquisition still looks expensive.
A panel of two halves for multiple myeloma Car-Ts
Carvykti sailed through Friday’s adcom, but Abecma got a much rougher ride.
FDA critics barely lay a glove on Geron
Imetelstat appears headed for approval after its US adcom turns into a damp squib.
Multiple myeloma Car-Ts face a US grilling
The FDA highlights high death rates and questions overall survival for Carvykti and Abecma.
Seven problems for Geron
Brutal FDA briefing documents raise questions about the approvability of imetelstat for myelodysplastic syndromes.
