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

Shares of prominent vaccine makers Moderna MRNA, BioNTech BNTX, Pfizer PFE, Novavax NVAX and Vaxcyte PCVX fell on Monday after the FDA announced plans to impose strict new vaccine requirements. What’s ...

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 ...

The FDA’s top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.

Pfizer offers value with a strong dividend, Metsera obesity expansion, PADCEV/Keytruda approval, and an oncology pipeline.

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

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

The ongoing Phase 3 clinical trial of Pfizer/BioNTech's coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday. The companies can now ...

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.

And one of them is pharmaceutical giant Pfizer ( PFE 0.04%). Now, with a major step along the path to entering this ...