FDA red and green lights: December 2025
Seven oncology approvals included nods for subcutaneous Rybrevant and Lunsumio.
Seven oncology approvals included nods for subcutaneous Rybrevant and Lunsumio.
Giredestrant’s adjuvant benefit looks similar to that of Kisqali and Verzenio.
And AbbVie and Genmab scoop their ASH presentation with new data.
An upcoming second-line SCLC phase 3 will include Imdelltra as a control option.
But it will be up to regulators to decide if giredestrant has done enough for an all-comers label.
The first pivotal data with raludotatug deruxtecan will feature as a late-breaker.
A Chinese phase 3 of the biparatopic DLL3 T-cell engager alveltamig will start soon.
The Kandlelit-007 trial will assess MK-1084 plus SC Keytruda across PD-L1 expression levels.