The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels ...

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to ...

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

FDA's new COVID-19 vaccine policy may restrict low-risk individuals' access, pending clinical trials to prove benefits.

FDA now requires Pfizer and Moderna COVID-19 vaccines to carry expanded warning labels about risks of myocarditis and pericarditis ...

The mRNA vaccines were developed using novel technology that was approved for the first time for public use during the COVID-19 pandemic.

On May 22, an FDA advisory committee unanimously recommended COVID-19 vaccine manufacturers target the JN.1 variant in their formulations.  The Vaccines and Related Biological Products Advisory ...

The vaccine advisory committee for the Food and Drug Administration met Thursday to discuss potential changes to the formula for COVID-19 vaccines for 2025-2026.

Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine ...