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

Another BCMA-targeted agent has arrived for the treatment of multiple myeloma. | After a delay, Regeneron’s BCMA-directed ...

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

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

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...

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 new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...

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

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 ...