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.
April saw a checkpoint inhibitor bonanza for Bristol and Akeso.
Data in HER2-mutated NSCLC still look good, and studies in HER2-amplified tumours continue.
The private US biotech features among recent first-in-human study entrants, with another PARP1-selective molecule.
Tough equity markets as well as competitor developments prompt a narrowed focus.
The FDA will rule on a low dose of zongertinib in the summer.
Just when investors thought things couldn't get any worse, they do.
The company has two actinium-labelled PSMA radiopharmaceuticals, and one is about to pivotal.
But could toxicity be holding back filing plans?