Marty Makary

FDA
Pharma

FDA launches new adverse event monitoring system

The new platform combines seven different adverse event dashboards into one, an effort that could save the agency $120 million over five years.
Zoey Becker Mar 12, 2026 11:04am
FDA

FDA approves leucovorin without clinical trial—but not for autism

Mar 10, 2026 9:00am
Prasad
Favicon Fierce Biotech

CBER Director Vinay Prasad to depart FDA—again

Mar 6, 2026 5:30pm
JNJ

Tecvayli-Darzalex combo earns national priority nod from FDA

Mar 6, 2026 8:00am
Red computer key with a warning symbol on it

FDA unleashes warning letters to firms selling compounded GLP-1s

Mar 4, 2026 8:30am
opening door to brick wall
Favicon Fierce Biotech

Senate hearing takes aim at FDA's rare disease review process

Feb 26, 2026 3:50pm