Blenrep against the odds
The FDA has cleared GSK’s drug again, after a no from the advisory committee.
ESMO 2025 movers – FDA volte-face to the rescue
Redemption of sorts comes for IO Biotech, but there’s no respite for Summit.
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.
