Marty Makary

Makary
Biotech

FDA unveils new pathway to speed custom gene editing therapies

Called the “plausible mechanism pathway,” the program is designed to offer a new way to market for personalized therapies, FDA officials said.
Angus Liu Nov 12, 2025 5:00pm
accelerated

Regeneron, Sanofi receive 1- to 2-month priority review vouchers

Oct 17, 2025 8:30am
FDA
Favicon Fierce Pharma

Under Trump, FDA seeks to abandon expert reviews of new drugs

Sep 12, 2025 9:50am
Image of a neon sign with the word no lit up next to an unlit yes

FDA rejects another ultrarare disease prospect

Sep 8, 2025 10:59am
FDA

FDA plans real-time release of drug rejection letters

Sep 4, 2025 1:45pm
yellow road to bright light

FDA proposes new approval pathway for rare diseases

Sep 3, 2025 1:20pm