Moderna, Inc.

Vinay Prasad, director of the US Food and Drug Administration’s Center for Biological Evaluation and Research, defended his recent decisions to overrule reviewers and grant narrower indications to thr

With 22 novel agents approved in the first six months of 2025, the US FDA is already behind its average approval count for the first half of the year, and the user fee calendar for the second half doe

An update to the label for Moderna’s Spikevax COVID-19 vaccine giving it full approval for young children reflects the overall more skeptical stance of the Trump Administration toward vaccines. And wh

US Food and Drug Administration staff are recommending routine safety monitoring of Merck and Co. ’s HPV vaccine, and Sanofi vaccines for seasonal influenza and dengue, after finding no new safety