Key Takeaways A new COVID booster might not be available this winterThe U.S. Food and Drug Administration is asking companies ...

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

Andrew Nixon, spokesman for Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., announced on ...

Scientists have found that receiving a COVID-19 booster shot in the same arm as the initial dose triggers a faster and more effective immune response, thanks to primed macrophages in nearby lymph ...

The U.S. Health and Human Services Department says it will require placebo testing of "all new vaccines," raising questions ...

More than 880 measles cases have been reported in the U.S. since February, including at least 660 in Texas, amid rising ...

Health Secretary Robert F. Kennedy Jr. on Thursday announced plans to require all new vaccines to be tested against placebos ...

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

FDA Chief Dr. Marty Makary said Tuesday that he'd "like to see some good data" on the vaccines before deciding whether to approve a new version later this year. Plus: Reuters reports that the CDC told ...