FDA green and red lights: June 2024
Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.
FDA critics barely lay a glove on Geron
Imetelstat appears headed for approval after its US adcom turns into a damp squib.
Seven problems for Geron
Brutal FDA briefing documents raise questions about the approvability of imetelstat for myelodysplastic syndromes.
Make or break time for Iovance
Lifileucel heads up the list of upcoming US FDA catalysts.
ASCO 2023 – Bristol’s Commands data look good for Geron
The limited activity of Reblozyl in myelodysplastic syndromes patients without ringed sideroblasts could help Geron.
