In its Friday approval letter, the FDA didn’t explain the restrictions although they reflect skepticism about ...

The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...

The U.S. Food and Drug Administration on Friday approved Novavax's COVID-19 vaccine, but placed additional conditions on ...

With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

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

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

The Trump administration plans to drop routine COVID vaccination guidance for kids and pregnant women, marking a major shift ...

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

The vaccine will only be available to those at high risk from Covid—excluding those who may need it to protect a relative or ...