"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

A former Pfizer scientist said the timing of the 2020 vaccine results “wasn’t a coincidence,” according to allegations ...

The GOP-led House Judiciary Committee is requesting records from Pfizer’s CEO and an interview with a former company ...

Top officials for the FDA laid out new requirements limiting access to yearly COVID shots for healthy younger adults and ...

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it ...

U.S. lawmakers on Thursday asked Pfizer Inc for information on alleged comments by a former executive suggesting its research ...