FDA red and green lights: August 2025
Boehringer’s Hernexeos beats Bayer’s sevabertinib to the US.
FDA doubles down on overall survival
New draft guidance could see the agency getting ever stricter.
The month ahead: August’s upcoming events
Jazz’s Chimerix buy faces its big test.
FDA red and green lights: June 2025
Controversial nods came for Urogen’s Zusduri and Astra/Daiichi’s Datroway.
FDA red and green lights: April 2025
April saw a checkpoint inhibitor bonanza for Bristol and Akeso.
AACR 2025 – Boehringer still has broad zongertinib hopes
Data in HER2-mutated NSCLC still look good, and studies in HER2-amplified tumours continue.
A second shot at PARP1 from Eikon
The private US biotech features among recent first-in-human study entrants, with another PARP1-selective molecule.
