FDA guidance

FDA
Biotech

FDA outlines draft policy on MRD for accelerated approval

The guidance provides recommendations for designing clinical trials that use MRD or CR as endpoints for accelerated approval in multiple myeloma.
Angus Liu Jan 21, 2026 2:55pm
VanNaarden

Lilly oncology head weighs in on FDA cancer drug policies

Oct 21, 2025 11:53am
Globe

FDA issues draft guidance for global cancer clinical trials

Sep 23, 2024 1:00pm
alzheimers brain neurodegenerative memory head

FDA revises guidance on predicting Alzheimer's drug benefits

Mar 12, 2024 7:40am
Gene editing gene therapy CRISPR

FDA gene editing guidance 'benign' but still important: analysts

Mar 16, 2022 10:55am
FDA

FDA calls on companies to be 'recall ready'

Mar 7, 2022 11:40am