J&J’s bladder hope gets its first approval
Inlexzo gets the nod in BCG-unresponsive non-muscle invasive bladder cancer, but the group has bigger plans.
Real transparency on FDA rejections
A new batch of CRLs includes fresh revelations about patritumab deruxtecan.
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New draft guidance could see the agency getting ever stricter.
BioNTech quietly drops Claudin6 work
A phase 2 trial of the Car-T project BNT211 is withdrawn just months after it began.
