This week, mRNA vaccines are set to face intense scrutiny from critics in Congress. Here's an explainer of how we know they are safe and effective.

For groups younger than 65 or without specific chronic conditions, postmarketing trials will be needed to open access.

A person attended a Shakira concert at the MetLife Stadium in New Jersey while infectious with measles. Health officials are ...

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

Earlier this month, the US government announced a US$500 million (£377 million) investment to accelerate research into ...

The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis ...

U.S. health officials knew about the risks of myocarditis from COVID-19 vaccines but downplayed the concern and delayed informing the public about the risks of taking the jab—that is according to a ...

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

In this week’s edition of InnovationRx, we look at the FDA's new rules on Covid-19 vaccines, Novartis’s acquisition strategy, ...

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

Regulators say updated booster shots won’t be approved for healthy people under age 65 unless drugmakers conduct new trials.