FDA doubles down on overall survival
New draft guidance could see the agency getting ever stricter.
FDA red and green lights: June 2025
Controversial nods came for Urogen’s Zusduri and Astra/Daiichi’s Datroway.
Better late than never for Datroway in lung cancer
Astra/Daiichi have trumped Gilead’s Trodelvy with a lung cancer approval.
NextCure joins Merck in an ovarian target
But the former is paying a fraction of what Merck shelled out for raludotatug.
ASCO 2025 – Enhertu mounts its first-line charge
Enhertu plus Perjeta shows a convincing progression-free survival benefit over a Perjeta triplet.
ASCO 2025 – Trodelvy heads for the front line
Gilead’s TROP2 ADC sets the bar for Astra/Daiichi’s Datroway in first-line TNBC.
ASCO 2025 – BioNTech’s latest Claudin6 effort falls short
BNT142 looks lacklustre, but the company still sees promise in mRNA-encoded bispecifics.
