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.
Astra and Daiichi bag FDA approval based on Destiny-Breast09.
The company leaves the door open for Trodelvy pre-chemo, despite Ascent-07’s failure.
But Enhertu is coming.
Both are heralded as a new first-line standard of care, but Datroway seems to have the edge.
Enhertu improves outcomes in (neo)adjuvant breast cancer, but toxicity resurfaces.
And Treeline and HengRui also get in on the pan-RAS act.