Government lawyer ignores leaked memo from FDA vaccines chief as she tries to convince appeals court to block Brook Jackson from refiling her False Claims Act case with new information such as vaccine ...

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...

Vaccine experts said the memo was irresponsible and omits key details about how officials arrived at the conclusion.

FDA chief medical officer Vinay Prasad told reporters that the agency would be changing its vaccine approval process.

In the wake of the memo, several vaccine experts responded that the CBER director's claim about the deaths requires more ...

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

Changes to the ways in which the FDA plans to regulate vaccines represent a threat to effective vaccines and public health, ...

Food and Drug Administration officials say they will ratchet up requirements for vaccine studies, citing concerns about COVID ...

More than a year after its promised deadline to investors, drugmaker puts alarming results in federal government's "virtual ...

FDA vaccines chief says internal review found 10 child deaths linked to Covid shots • Shift would remake flu immunization ...

Shares of several major vaccine makers lost ground Monday following a report U.S. vaccine approval rules could become ...

Pfizer's coronavirus vaccine could face some headwinds in the near future. The company will enter a period of patent cliffs ...