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

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

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

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

The news devastated the researchers, who live and work in a region where more people live with HIV than anywhere else in the ...

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

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

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 ...

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

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

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 from vaccine makers Novavax and ...