Moderna MRNA announced that the FDA has approved its supplemental biologics license application seeking approval for COVID-19 ...

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

Novavax's growth relies on Sanofi royalties and COVID/flu vaccines, lacking innovation and clear catalysts. Click here to ...

Pfizer's COVID vaccine (Comirnaty) is fully approved for patients ages 12 and up, and authorized for kids ages 6 months ...

South Africa has played a historic, global role in scientific research, from COVID-19 vaccines to HIV. Now that's under ...

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...

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

Federal documents show he disagreed with conclusions the benefits outweighed the risk of side effects, which are rare.

Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.

While both the Novavax vaccine and the newest generation of the mRNA Moderna vaccines had been signed off on by about 30 FDA vaccine officials, Prasad ended up writing overrides for each, restricting ...

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