FDA red and green lights: November 2025
The agency approved eight oncology products over the month.
Revolution goes adjuvant
The upcoming Rasolute-304 trial will compare daraxonrasib versus observation.
Chinese biotechs push on into the clinic
Car-T therapies and ADCs feature among recent first-in-human study entrants.
Summit joins the global colorectal fight
The pivotal Harmoni-GI3 study has started enrolling patients.
HengRui goes pivotal in KRAS G12D
The group will take HRS-4642 into a Chinese phase 3 in first-line pancreatic cancer.
After SpringWorks, Immunome has a Ringside seat
Varegacestat’s pivotal study reads out imminently.
BioNTech’s big gotistobart day approaches
Readout of the Preserve-003 trial in post-PD-(L)1 NSCLC is due in December.
The month ahead: December’s upcoming events
ASH and SABCS approach.
