US shutdown freezes new drug applications
Key FDA decisions are expected to face delays.
FDA red and green lights: September 2025
A single-arm trial was enough for J&J’s Inlexzo nod.
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.
