IND

FDA launches pilot program to speed up sluggish phase 1 trials

The program is part of what the FDA calls Operation Trial Blazer, announced in June, and will also include other efforts across the Department of Health and Human Services.

Darren Incorvaia Sep 15, 2026 2:09pm

Martin Makary FDA Senate HELP confirmation

Makary FDA reforms ‘continue to move forward’ despite turmoil

May 26, 2026 10:27am

Denali ph. 1 Pompe plans hit with clinical hold

Dec 4, 2025 11:52am

FDA proposes higher fees for ph. 1 trials conducted outside of US

Dec 3, 2025 5:19pm

After delay, Coya receives FDA go-ahead for phase 2 ALS trial

Aug 25, 2025 11:04am

Two white lab rats looking out of a cage

FDA plans to end animal testing for new monoclonal antibody INDs

Apr 11, 2025 1:22pm