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.
An in vivo Car-T produced a 100% response rate – in three patients.
The Rainfol-04 trial in platinum-sensitive ovarian cancer will start next year.
But it will be up to regulators to decide if giredestrant has done enough for an all-comers label.
The company reveals the first overall survival data in adjuvant ER-positive breast cancer.
First data with Astra’s torvutatug samrotecan come as Lilly unveils its first folate pivotal trial.
The Kandlelit-007 trial will assess MK-1084 plus SC Keytruda across PD-L1 expression levels.