FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...

But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 ...

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

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

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

Vaccine makers are required to run fresh clinical trials before offering shots to younger and healthier individuals. Read ...

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. FDA Commissioner Marty Makary, M.D., and Center for Biologics ...

FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...

Regulators will require more data showing the shots are safe and effective for healthy adults and children, by requiring ...

New FDA framework on changes coronavirus vaccine approval will be released “in the coming days,” FDA Commissioner Marty ...