Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 ...

How did we get here? Until now, vaccines for all children under age 12 had been available under emergency use authorization ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccines ...

Biohaven’s valuation has dropped from $3.9B to $1.42B, but no revenue and high cash burn still limit its appeal. Read why ...

The amended dosing regimen was approved based on results from a post hoc analysis of the phase 2 MagnetisMM-3 trial.

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots.

Newly released documents show the FDA’s vaccine chief, Dr. Vinay Prasad, intervened to restrict approval of two new shots from vaccine makers Novavax and Moderna.

FDA vaccine head Vinay Prasad restricted Moderna and Novavax COVID vaccines to high-risk groups, overriding staff advice amid concerns about rare side effects.

Pfizer's COVID vaccine (Comirnaty) is fully approved for patients ages 12 and up, and authorized for kids ages 6 months through 11 years. Novavax's COVID shot (Nuvaxovid) is fully approved for people ...