CBER

FDA

Pharma

FDA signs off on 1st gene therapy for rare genetic disease

Fondazione Telethon's Waskyra is an ex vivo gene therapy that can address the root genetic cause of Wiskott-Aldrich syndrome.

Zoey Becker Dec 10, 2025 12:09pm

Vinay Prasad

FDA's Prasad plans to get tougher on vaccine regulation: memo

Dec 1, 2025 11:25am

Marks

Fierce Biotech

Former FDA official Peter Marks joins Eli Lilly

Oct 7, 2025 3:49pm

stack of letters mail envelopes

FDA targets Big Pharma in deluge of marketing letters

Sep 16, 2025 1:55pm

AstraZeneca FluMist Home ad

AstraZeneca TV spot for at-home FluMist lands in FDA crosshairs

Sep 16, 2025 11:07am

FDA

Vinay Prasad is back at the FDA after last month's surprise ouster

Aug 9, 2025 12:22pm