FDA red and green lights: June 2025
Controversial nods came for Urogen’s Zusduri and Astra/Daiichi’s Datroway.
Controversial nods came for Urogen’s Zusduri and Astra/Daiichi’s Datroway.
The company’s BG-C9074 looks competitive, but there are questions about cutoffs and confirmed responses.
Astra/Daiichi have trumped Gilead’s Trodelvy with a lung cancer approval.
A new phase 3 could see ivonescimab challenge AstraZeneca’s Imfinzi in limited-stage disease.
Enhertu plus Perjeta shows a convincing progression-free survival benefit over a Perjeta triplet.
But camizestrant’s use could depend on uptake of monitoring – for now.
Any hopes of differentiation could come down to side effects.
Gilead’s TROP2 ADC sets the bar for Astra/Daiichi’s Datroway in first-line TNBC.
Crunch time approaches for UroGen.