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

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...

FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may ...

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

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