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.
The new normal in US oncology approvals
Nearly two thirds of key oncology filings are expedited; and what about the ones that aren’t?
