The Food and Drug Administration announced a major shift Tuesday on how COVID-19 vaccines will be approved—and it could mean ...

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over ...

Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people ...

A new FDA framework for Covid-19 vaccines created confusion among physicians about what it means for young children ...

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...

Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, explained that the changes aim ...

The FDA says the new approach will aim to balance a timely approval process for vaccines, while also weighing “the need for ...

Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for ...

COVID vaccines are only approved for elderly and a few others as RFK continues to reshape how Americans fight disease - ...

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.