US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

The U.S. Food and Drug Administration (FDA) announced plans to require new clinical trials for annual COVID-19 booster ...

The Trump administration said it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else.

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...

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

Moderna, Inc. (NASDAQ:MRNA) shares soared to the top of the S&P 500 gainers in early afternoon trading on May 20, surging by ...

The FDA says the new approach will aim to balance a timely approval process for vaccines, while also weighing “the need for evidence" of their effectiveness for the masses.

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.

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...