Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

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

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

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.

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

Moderna stock jumps 4.5% as the FDA grants full approval for its COVID-19 vaccine in high-risk individuals aged six months to ...

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

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 ...

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 ...

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...