The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

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

This week, two new leaders at the US Food and Drug Administration announced plans to limit access to covid vaccines, arguing ...

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period ...

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

At CTO West Coast, an expert discussed the implications of the FDA’s expedited approval programmes with a spotlight on ...

Despite the fact that vaccines against COVID have already undergone strict safety reviews and that people continue to die ...

At the outset of the meeting, the FDA's new top vaccine regulator, Vinay Prasad, said he and FDA leaders wanted to "give people a little more time to digest the policy." He said that the FDA is still ...

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain ...

The U.S. Food and Drug Administration's advisory panel is set to vote on Thursday to recommend whether COVID-19 vaccines for ...