The FDA’s new approach to boosters could mean that kids will no longer be able to get vaccinated against the disease to begin ...

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

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

A hot (if cautious) topic at the big gene therapy meeting: what Vinay Prasad's appointment might mean for approvals in rare ...

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

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

"With the COVID pandemic behind us, it is time to adopt a common-sense approach to COVID policy," a spokesperson for the FDA ...

At the American Society of Cell and Gene Therapy conference, there were questions and qualms on how Vinay Prasad may change ...

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which ...

We want to know more about what these products are doing,” said Dr. Vinay Prasad during a recent FDA livestreamed ...

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