Food and Drug Administration (FDA)

Blood sample microscope study clinical trial lab research
CRO

FDA issues draft guidance on clinical trial tissue biopsies

The FDA recommends only requiring biopsies if they are needed to determine a patient’s eligibility for the trial or to assess a key endpoint.
Darren Incorvaia Jan 6, 2025 2:55pm
Parachute over ocean with sunset behind

FDA's principal deputy to depart agency—Chutes & Ladders

Dec 20, 2024 8:30am
FDA stop sign

FDA hits pause on another of PepGen's muscular dystrophy trials

Dec 16, 2024 9:45am
FDA stop sign

FDA hits Kezar's zetomipzomib with 2nd clinical hold in 2 months

Nov 13, 2024 5:22am
AstraZeneca

AstraZeneca, Daiichi pull lung cancer BLA for Enhertu follow-up

Nov 12, 2024 5:27am
FDA stop sign

FDA places Rapport's nerve damage trial on hold

Nov 7, 2024 8:50am