Martin Makary

speedy fast accelerated review accelerated approval racetrack race track quick
Manufacturing

USAntibiotics scores first FDA national priority voucher nod

The FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner's National Priority Voucher pilot program.
Fraiser Kansteiner Dec 10, 2025 2:30pm
FDA
Favicon Fierce Biotech

FDA names Tracy Beth Høeg as acting head of drug center

Dec 4, 2025 4:03am
Makary
Favicon Fierce Biotech

2 lawmakers push for answers as questions swirl over FDA program

Nov 25, 2025 10:30am
Richard Pazdur

FDA names oncology vet Pazdur as new CDER director

Nov 11, 2025 5:18pm
Capitol in Washington DC

How a government shutdown will affect the FDA

Oct 1, 2025 11:29am
FDA

FDA takes close look at mifepristone REMS program

Sep 25, 2025 11:00am