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

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

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

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

Presented by The Coalition to Strengthen America’s Healthcare — The Trump administration on Tuesday said it plans to limit ...

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

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

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

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

Schrodinger delivers strong Q1 results, driven by software growth and evolving FDA regulations. Read more to see why SDGR ...

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