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

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

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

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

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

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

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

Retail investor chatter around vaccine makers Novavax, Moderna, and Pfizer rose on Wednesday, ahead of a closely watched CDC vaccine advisory meeting. At Wednesday’s close, Novavax closed down 0.2% at ...

As for Nuvaxovid, this standalone Novavax Covid-19 vaccine received its FDA approval in May, a regulatory decision that covers its use in those age 65 and older.

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

The U.S. FDA approved 14 drugs in May, a decline from 20 in April and 22 in March. That brings the year-to-date total for 2025 to 84 approvals, the second highest on record for this period, just ...