Shots would be available to those 65 and older and for those older than 6 months of age who have health conditions that make ...

But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 ...

The FDA is getting rid of the Covid booster because . . . it's concerned about anti-vaxx sentiments. No, really.

The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis ...

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

In this week’s edition of InnovationRx, we look at the FDA's new rules on Covid-19 vaccines, Novartis’s acquisition strategy, ...

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

Tracy Beth Høeg, MD, PhD, a sports medicine physician focused on ultramarathon runners who rose to prominence by challenging ...

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which ...

A day after the FDA tightened the restrictions for winning vaccine approvals, Moderna Inc. is pulling its application for ...

Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people ...