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Food and Drug Administration (FDA)
CRO
FDA draft recommends all cancer trials collect OS data
Even when OS is not used as the primary endpoint, the FDA still advises that trial sponsors collect and submit survival data to the regulator.
Darren Incorvaia
Aug 20, 2025 10:59am
Regenxbio's Hunter gene therapy latest to face FDA delay
Aug 19, 2025 10:30am
Another biotech hit with FDA delay for ALS asset
Aug 18, 2025 11:01am
FDA delays Omeros' 2nd attempt at transplant drug’s approval
Aug 15, 2025 5:55am
Big Pharma-backed program seeks future beyond animal testing
Aug 1, 2025 5:00pm
Kezar sees hepatitis hold lifted, mulls restarting lupus program
Jul 16, 2025 8:47am
